ASC ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
36表皮水疱症3
51全身性強皮症6
96クローン病18
97潰瘍性大腸炎33

36. 表皮水疱症


臨床試験数 : 163 薬物数 : 185 - (DrugBank : 46) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 125
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05157958
(ClinicalTrials.gov)
November 1, 20222/12/2021Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET in Subjects With Dystrophic Epidermolysis BullosaDouble Blind, Randomized, Phase II Clinical Study to Evaluate Safety and Efficacy of ALLO-ASC-SHEET Versus Vehicle Control in Dystrophic Epidermolysis Bullosa (DEB) PatientsDystrophic Epidermolysis BullosaBiological: ALLO-ASC-SHEET;Other: Vehicle ControlAnterogen Co., Ltd.NULLNot yet recruiting4 Years60 YearsAll6Phase 2NULL
2NCT03752905
(ClinicalTrials.gov)
January 9, 201919/11/2018A Phase 1/2 Trial of PTR-01 in Adult Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)A Phase 1/2 Randomized, Saline-Controlled, Single-Blind, Multiple Ascending Dose, Dose-Escalation, Multi-Center Trial of PTR-01 in Adult Patients With Recessive Dystrophic Epidermolysis Bullosa (RDEB)Recessive Dystrophic Epidermolysis BullosaDrug: PTR-01;Drug: Normal salinePhoenix Tissue Repair, Inc.NULLCompleted16 YearsN/AAll12Phase 1/Phase 2United States
3NCT03183934
(ClinicalTrials.gov)
July 20178/6/2017A Follow-up Study to Evaluate the Efficacy and Safety of ALLO-ASC-DFU in ALLO-ASC-EB-101 Clinical TrialA Follow-up Study to Evaluate the Efficacy and Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1/2 Clinical Trial of ALLO-ASC-EB-101Dystrophic Epidermolysis BullosaBiological: ALLO-ASC-DFUAnterogen Co., Ltd.NULLNot yet recruiting2 Years60 YearsAll5Phase 1/2Korea, Republic of

51. 全身性強皮症


臨床試験数 : 525 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05029336
(ClinicalTrials.gov)
September 202324/8/2021Autologous Stem Cell Transplant (ASCT) for Autoimmune DiseasesAutologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune DiseasesSystemic Lupus Erythematosus;Systemic SclerosisBiological: Depletion of CD3/CD19 in an autologous stem cell transplantStephan Grupp MD PhDNULLRecruiting8 Years25 YearsAll20Phase 2United States
2NCT04948554
(ClinicalTrials.gov)
March 10, 20234/6/2021A Study of MK-2225 / ACE-1334 in Participants With Systemic Sclerosis With and Without Interstitial Lung Disease (MK-2225-002)A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of ACE-1334 Plus Standard of Care in Participants With Systemic SclerosisSystemic Sclerosis With and Without Interstitial Lung DiseaseBiological: MK-2225;Biological: PlaceboAcceleron Pharma Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)NULLRecruiting18 YearsN/AAll48Phase 1United States;Canada
3NCT05462522
(ClinicalTrials.gov)
January 16, 202314/7/2022A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic SclerosisA Phase Ib, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple-Ascending Doses of RO7303509 in Participants With Systemic SclerosisSystemic SclerosisDrug: RO7303509;Drug: PlaceboGenentech, Inc.NULLRecruiting18 Years75 YearsAll100Phase 1United States;Belgium;France;Israel;Poland;Puerto Rico;Spain
4NCT04356755
(ClinicalTrials.gov)
September 22, 202011/3/2020Subcutaneous Injections of Autologous ASC to Heal Digital Ulcers in Patients With Scleroderma.Subcutaneous Injections of Autologous Cultured Adipose-derived Stroma/ Stem Cells to Heal Refractory Ischemic Digital Ulcers in Patients With SclerodermaSystemic SclerosisProcedure: Adipose tissue harvest;Drug: Autologous ASC;Drug: PlaceboUniversity Hospital, ToulouseNULLRecruiting18 YearsN/AAll32Phase 2France
5EUCTR2019-003906-28-FR
(EUCTR)
24/02/202018/11/2019Adipose tissu derived-stem cells injections from patients with sclerodermia to treat thier refractory digital ulcers.Subcutaneous injections of autologous cultured adipose-derived stroma/stem cells to heal refractory ischemic digital ulcers in patients with scleroderma : a phase II study - ADUSE Patients with systemic sclerosis presenting digital ulcer :- located beyond the proximal interphalangeal joint, on finger surface (included periungueal ulcers),- of ischemic origin according to the physician,- not over subcutaneous calcifications or bone relief,- active DU- refractory after 10±2 weeks of standard of care (that is either still active or new occurrence despite standard of care);Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: autologous ASCCHU de ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
32Phase 2France
6NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain

96. クローン病


臨床試験数 : 2,442 薬物数 : 1,278 - (DrugBank : 248) / 標的遺伝子数 : 142 - 標的パスウェイ数 : 209
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT05659953
(ClinicalTrials.gov)
March 1, 202325/11/2022LMT503 First-in-human SAD, MAD, and FE StudyA Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LMT503 in Healthy SubjectsColitis, Ulcerative;Crohn Disease;Inflammatory Bowel DiseaseDrug: LMT503;Drug: PlaceboLmito Therapeutics Inc.NULLNot yet recruiting18 Years65 YearsAll72Phase 1Netherlands
2NCT05028946
(ClinicalTrials.gov)
May 1, 202224/8/2021A Study of Oral Foralumab in Participants With Moderate to Severely Active Crohn's DiseaseA Phase IB Multiple Ascending Dose Study of Safety and Tolerability of Orally Administered Foralumab, a Fully Human Anti-CD3 Monoclonal Antibody, in Subjects With Moderate to Severely Active Crohn's DiseaseCrohn's DiseaseDrug: ForalumabTiziana Life Sciences, PLCNULLWithdrawn18 Years70 YearsAll0Phase 1NULL
3EUCTR2019-001866-14-IT
(EUCTR)
21/12/202112/10/2021Open-label Extension Study of Brazikumab in Crohn's DiseaseAn Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) - INTREPID OLE Moderately to Severely Active Crohn's Disease.
MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of
4ChiCTR2000037094
2020-09-012020-08-26Discovery and detection of a novel antigen for Crohn’s disease (CD)Discovery and detection of a novel antigen for Crohn’s disease (CD) Inflammatory Bowel DiseaseGold Standard:Chinese consensus on diagnosis and treatment in inflammatory bowel disease (2018, Beijing);Index test:anti-CABP, pANCA, ASCA;The First Affiliated Hospital of Anhui Medical UniversityNULLCompleted1880BothTarget condition:100;Difficult condition:100China
5NCT03183661
(ClinicalTrials.gov)
November 16, 20168/6/2017A Follow-up Study to Evaluate the Safety of ALLO-ASC-CD in ALLO-ASC-CD-101 Clinical TrialFollow-up Study to Evaluate the Safety of ALLO-ASC-CD in the Subjects With Crohn´s Disease(ALLO-ASC-CD-101)Crohn DiseaseBiological: ALLO-ASC-CDAnterogen Co., Ltd.NULLEnrolling by invitation18 Years65 YearsAll9N/ANULL
6NCT02749630
(ClinicalTrials.gov)
April 11, 201612/4/2016A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.NULLCompleted18 Years80 YearsAll70Phase 1Germany;United Kingdom;Canada
7NCT02580617
(ClinicalTrials.gov)
April 201515/10/2015A Study to Evaluate the Safety of ALLO-ASC-CD for Treatment of Crohn's DiseaseA Phase 1 Clinical Study to Evaluate the Safety of Allogeneic Adipose-derived Stem Cells in the Subjects With Crohn's DiseaseCrohn's DiseaseBiological: ALLO-ASCAnterogen Co., Ltd.NULLRecruiting18 Years65 YearsAll9Phase 1Korea, Republic of
8NCT02249078
(ClinicalTrials.gov)
December 201423/9/2014A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseA Multicenter, Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Sequential-Cohort, Multiple-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 3 Subcutaneous and 1 Intravenous Dose of E6011 in Subjects With Active Crohn's DiseaseCrohn's DiseaseDrug: E6011;Drug: PlaceboEisai Inc.NULLWithdrawn18 YearsN/ABoth0Phase 1NULL
9NCT01258205
(ClinicalTrials.gov)
February 28, 20119/12/2010Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease SubjectsA Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's DiseaseCrohn's DiseaseDrug: AMG 139AstraZenecaNULLCompleted18 Years55 YearsAll48Phase 1United States;Australia
10NCT01290042
(ClinicalTrials.gov)
February 201127/1/2011Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.Ulcerative Colitis;Crohn's DiseaseDrug: AMG 181;Other: Placebo for AMG 181AmgenNULLCompleted18 Years65 YearsBoth43Phase 1United States;Australia
11NCT01611805
(ClinicalTrials.gov)
July 22, 201012/4/2012Japanese Phase I of GSK1605786A Placebo-Controlled, Four-Period Crossover, Single Ascending Oral Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of the CCR9 Receptor Antagonist GSK1605786 in Japanese Healthy Male SubjectCrohn's DiseaseDrug: GSK1605786;Drug: GSK1605786 PlaceboGlaxoSmithKlineNULLCompleted20 Years55 YearsMale30Phase 1Australia
12NCT00950105
(ClinicalTrials.gov)
July 200929/7/2009Single Ascending Dose Study of Oral CPSI-2364 (Semapimod)A Phase 1, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Oral CPSI-2364 in Healthy SubjectsCrohn's DiseaseDrug: CPSI-2364 or placeboFerring PharmaceuticalsNULLCompleted18 Years55 YearsBoth30Phase 1United States
13EUCTR2008-004286-25-DE
(EUCTR)
28/04/200921/08/2008Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT IIRandomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease.FATT 2: Fistula Advanced Therapy Trial (II) - FATT II Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
196Phase 3Czech Republic;Germany;Netherlands;Belgium;Spain;Austria
14EUCTR2008-004286-25-BE
(EUCTR)
30/03/200911/09/2008Randomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT IIRandomized, single-blind, placebo-controlled multicenter phase III study to assess the efficacy and safety of expanded autologous adipose-derived stem cells (eASCs) (CX-401), for treatment of complex perianal fistulas in Crohn’s disease. FATT 2: Fistula Advanced Therapy Trial (II) - FATT II Complex perianal fistula in perianal Crohn´s disease
MedDRA version: 9;Level: LLT;Classification code 10002156;Term: Anal fistula
Product Name: ASCs: Adipose derived Stem Cells
Product Code: Cx401
INN or Proposed INN: ASCs
Other descriptive name: Suspension of adipose derived autologous adult stem cells
CELLERIX S.A.NULLNot RecruitingFemale: yes
Male: yes
196Phase 3Czech Republic;Germany;Netherlands;Belgium;Spain;Austria
15NCT01429922
(ClinicalTrials.gov)
January 200929/8/2011Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending DoseDouble Blind Placebo-controlled,Safety and Tolerability of ZP1848 Administered as Ascending Single Dose SUBCUTANEOUS Bolus Injections in Healthy Subjects Followed by Multiple Dose Cohort of Patients With Stable Crohn's Disease in RemissionCrohns DiseaseDrug: ZP1848MDS Pharma ServicesNULLCompleted18 Years50 YearsBoth60Phase 1/Phase 2United States
16NCT01378390
(ClinicalTrials.gov)
December 200821/6/2011Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's DiseaseRandomized, Single-blind, Placebo Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Expanded Autologous Adipose-derived Stem Cells (ASCs) (CX-401), for Treatment of Complex Perianal Fistulas in Perianal Crohn's DiseaseComplex Perianal Fistula;Crohn DiseaseDrug: Expanded autologous adipose-derived adult stem cells (eASCs);Drug: PlaceboTigenix S.A.U.NULLTerminated18 YearsN/AAll56Phase 3Austria;Netherlands;Spain
17EUCTR2008-003167-39-BE
(EUCTR)
17/09/200828/08/2008Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn.Effet du fluconazole sur le taux d'anticorps anti-Saccharomyces cerevisiae (ASCSA) après résection chirurgicale pour maladie de Crohn. Crohn' disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Trade Name: diflucan
INN or Proposed INN: FLUCONAZOLE
Cliniques Universitaires Saint LucNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Belgium
18NCT02997059
(ClinicalTrials.gov)
July 200814/12/2016Effect of Fluconazole on the Levels of ASCA After Surgical Resection for Crohn's Disease.Effect of Fluconazole on the Levels of Anti-Saccharomyces Cerevisiae Antibodies (ASCA) After Surgical Resection for Crohn's Disease. Multicenter, Randomized, and Controlled in Two Parallel Groups Versus PlaceboCrohn's Disease AggravatedDrug: Fluconazole;Other: PlaceboUniversity Hospital, LilleMinistry of Health, FranceTerminated18 YearsN/ABoth35Phase 2France

97. 潰瘍性大腸炎


臨床試験数 : 2,630 薬物数 : 1,459 - (DrugBank : 265) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-001644-10-IT
(EUCTR)
21/12/202117/09/2021Open-label Extension Study of Brazikumab in Ulcerative ColitisA Phase 2 Open-label, Long-term Extension Safety Study of Brazikumab in Participants with Moderately to Severely Active Ulcerative Colitis(EXPEDITION OLE) - EXPEDITION OLE Ulcerative Colitis
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
Product Name: Brazikumab
Product Code: [MEDI2070]
INN or Proposed INN: ( L ) ASCORBATO DI CALCIO
Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as 'MEDI2070'
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Czechia;Taiwan;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Japan;Korea, Republic of
2NCT05084261
(ClinicalTrials.gov)
November 30, 202120/9/2021An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)A Multicenter, Randomized, Placebo-Controlled, Multiple-Ascending-Dose Investigation of the Oral Anti-Inflammatory Agent BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)Ulcerative ColitisDrug: BT051 200 mg;Drug: BT051 800 mg;Drug: BT051 3200 mg;Drug: Matching PlaceboAdiso TherapeuticsNULLCompleted18 Years75 YearsAll24Phase 1United States;Georgia;Moldova, Republic of;Poland;Ukraine
3NCT04457960
(ClinicalTrials.gov)
July 1, 20201/7/2020A Study of JNJ-66525433 in Healthy Participants and Participants With Ulcerative ColitisA Phase 1, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Participants and Multiple Dose Study in Participants With Ulcerative Colitis to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-66525433Healthy;Colitis, UlcerativeDrug: JNJ-66525433;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 Years60 YearsAll140Phase 1Georgia;Germany;Moldova, Republic of
4NCT04224857
(ClinicalTrials.gov)
April 1, 201923/5/2019SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose in Healthy Subjects and Multiple-Ascending Dose in Adult Patients With Ulcerative Colitis Study to Evaluate the Safety, Tolerability, PK and PD of Oral AMT-101Ulcerative ColitisDrug: AMT-101;Drug: PlacebosApplied Molecular TransportNULLCompleted18 YearsN/AAll52Phase 1Georgia;Germany;Moldova, Republic of;Ukraine
5NCT03581149
(ClinicalTrials.gov)
March 26, 201827/3/2018Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis PatientsTolerability and Efficacy of Low-Volume Sodium Picosulfate/Magnesium Citrate Versus 2L Polyethylene Glycol/Ascorbic Acid in Patients With Ulcerative Colitis Undergoing Colonoscopy: A Randomized Controlled TrialUlcerative ColitisDrug: Sodium Picosulfate/Magnesium Citrate Laxative;Drug: 2L polyethylene glycol/ascorbic acidAmerican University of Beirut Medical CenterNULLRecruiting18 Years65 YearsAll68Phase 4Lebanon
6NCT03482648
(ClinicalTrials.gov)
March 20, 201817/3/2018First-In-Human Study of BBT-401-1S Following Single and Multiple Ascending Doses in Healthy VolunteersA Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Novel Oral Peptide BBT-401-1S Following Single and Multiple Ascending Doses in Healthy Adult SubjectsUlcerative ColitisDrug: BBT-401-1S, Single dose;Drug: BBT-401-1S, Multiple doses;Drug: PlaceboBridge Biotherapeutics, Inc.KCRN Research, LLCCompleted19 Years55 YearsAll80Phase 1United States
7NCT03103412
(ClinicalTrials.gov)
May 4, 201724/3/2017TD-3504 SAD in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Study 0146: A Phase 1a, Double-Blinded, Randomized, Placebo Controlled, Single Ascending Dose (SAD) Study to Evaluate the Safety, Tolerability, and Systemic Exposure of TD-3504 in Healthy Subjects and Subjects With Ulcerative Colitis (UC)Active Mild Ulcerative Colitis, Active Moderate Ulcerative Colitis, Healthy SubjectsDrug: TD-3504;Drug: 15N2-tofacitinib;Drug: PlaceboTheravance BiopharmaNULLCompleted18 Years55 YearsAll32Phase 1United States
8NCT03071081
(ClinicalTrials.gov)
February 8, 201720/2/2017Study for Safety and Tolerability of TOP1288 Administered Orally in Healthy SubjectsA Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TOP1288 Oral Single Ascending and Multiple Doses in Healthy VolunteersUlcerative ColitisDrug: TOP1288;Drug: Placebo to TOP1288Topivert Pharma LtdNULLCompleted18 Years55 YearsMale37Phase 1United Kingdom
9NCT03038711
(ClinicalTrials.gov)
February 1, 201726/1/2017A Multiple Dose Study to Assess the Safety and Tolerability of BMS-986166 in Healthy VolunteersA Randomized, Double Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-986166 in Healthy SubjectsUlcerative ColitisDrug: BMS-986166;Other: Placebo matching BMS-986166Bristol-Myers SquibbNULLCompleted18 Years55 YearsAll213Phase 1United States
10NCT02864264
(ClinicalTrials.gov)
September 14, 20169/8/2016Single Ascending Dose and Multiple Ascending Dose Study in Healthy Participants and Proof of Mechanism Study in Patients With Ulcerative ColitisDouble-Blind, Randomized, Placebo-Controlled, Single Ascending and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Target Engagement of BMS-986184 in Healthy Subjects and to Evaluate the Safety, Efficacy, Pharmacokinetics, Target Engagement, and Pharmacodynamics of BMS-986184 in Patients With Moderate to Severe Ulcerative ColitisHealthy Volunteers;Ulcerative ColitisDrug: BMS-986184;Drug: Placebo matching BMS-986184Bristol-Myers SquibbNULLTerminated18 Years75 YearsAll7Phase 1Australia;Georgia;Moldova, Republic of;Romania
11NCT02647866
(ClinicalTrials.gov)
June 20168/12/2015Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative ColitisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) & Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderately Active UCUlcerative Colitis;Digestive System Diseases;Colitis, Ulcerative;Colitis;Gastrointestinal Diseases;Inflammatory Bowel Diseases;Intestinal Diseases;Colonic Diseases;Autoimmune Disease;Abdominal PainDrug: KHK4083;Drug: PlaceboKyowa Kirin Pharmaceutical Development, Inc.NULLCompleted18 YearsN/AAll66Phase 2United States;Czechia;Hungary;Poland;Romania;Russian Federation;Serbia;Czech Republic;Puerto Rico
12EUCTR2015-001555-69-PL
(EUCTR)
28/04/201622/12/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Romania;Russian Federation
13NCT02749630
(ClinicalTrials.gov)
April 11, 201612/4/2016A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)An Observer-Blinded, Placebo-Controlled, Multiple-Ascending, Dose-Escalation Study to Explore the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeat Intravenous Administrations of UTTR1147A in Healthy Volunteers and Patients With Ulcerative Colitis and Crohn's DiseaseUlcerative Colitis;Crohn's DiseaseDrug: Placebo;Drug: UTTR1147AGenentech, Inc.NULLCompleted18 Years80 YearsAll70Phase 1Germany;United Kingdom;Canada
14EUCTR2015-001555-69-CZ
(EUCTR)
07/03/201614/12/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis. A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Hungary;Czech Republic;Poland;Russian Federation
15NCT02818543
(ClinicalTrials.gov)
March 201630/3/2016Safety and Pharmacokinetic Study of LYC-30937 in Subjects With Active Ulcerative ColitisAn Open-Label, Single Ascending Dose Study To Evaluate The Pharmacokinetic Profile, Safety and Tolerability of Orally Administered LYC-30937 in Subjects With Active Ulcerative ColitisUlcerative ColitisDrug: LYC-30937Lycera Corp.NULLCompleted18 Years75 YearsBoth6Phase 1Hungary
16EUCTR2015-001555-69-HU
(EUCTR)
15/01/201617/11/2015A clinical study to test the safety and possible benefits of an investigational study drug, KHK4083, in patients with ulcerative colitis.A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Multiple Ascending Dose Study (Induction Therapy) and Long-term Extension Therapy of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis, defined as:•Total Mayo Clinic score of 4 to 9 (range: 0 to 12, with higher scores indicating more disease activity);•Endoscopy subscore (mMES determined by a central reader) of at least 2; and•Disease that extends = 15 cm from the anal verge.
MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: KHK4083
Product Code: KHK4083
INN or Proposed INN: Not available
Kyowa Kirin Pharmaceutical Development, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Serbia;United States;Czech Republic;Hungary;Poland;Russian Federation
17NCT02463045
(ClinicalTrials.gov)
May 201526/5/2015Study for Safety and Tolerability of TOP1288 Administered Rectally in Healthy and Ulcerative Colitis SubjectsA Phase I Study to Evaluate the Safety/Tolerability and Pharmacokinetics of TOP1288 Rectal Single and Multiple Ascending Doses in Healthy Subjects and Multiple Doses in Subjects With Ulcerative ColitisUlcerative ColitisDrug: TOP1288Topivert Pharma LtdNULLCompleted18 Years55 YearsAll67Phase 1United Kingdom
18NCT01929668
(ClinicalTrials.gov)
August 201323/8/2013Comparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Inactive UC PatientsComparison of 4L Polyethylene Glycol and 2L Polyethylene Glycol With Ascorbic Acid in Patients With Inactive Ulcerative Colitis; Randomized, Single Blind, Multicenter StudyUlcerative ColitisDrug: polyethylene glycol;Drug: Ascorbic AcidKyungpook National UniversityNULLCompleted18 Years80 YearsBoth114N/AKorea, Republic of
19NCT01914887
(ClinicalTrials.gov)
June 201318/7/2013Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells for the Induction of Remission in Ulcerative ColitisA Phase I/IIa Clinical Trial to Evaluate Safety and Efficacy of Adipose Tissue-derived Mesenchymal Stem Cells (ASC) on Induction to Remission in Ulcerative ColitisUlcerative ColitisDrug: Allogeneic adipose tissue-derived mesenchymal stem cellsInstituto de Investigación Hospital Universitario La PazFundacion para la Investigacion Biomedica del Hospital Universitario la Paz;Ministry of Health, SpainRecruiting18 YearsN/ABoth8Phase 1/Phase 2Spain
20NCT01831427
(ClinicalTrials.gov)
March 20138/4/2013Evaluating the Safety, Pharmacokinetics and Efficacy of GS-5745 in Adults With Moderately to Severely Active Ulcerative ColitisA Phase 1 Double-blind, Randomized, Placebo-Controlled, Staggered, Single and Multiple Ascending Dose, Multicenter Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 in Subjects With Moderate to Severe Ulcerative ColitisUlcerative ColitisDrug: GS-5745;Drug: Placebo to match GS-5745Gilead SciencesNULLCompleted18 Years65 YearsAll74Phase 1United States;Belgium;Canada;Hungary;Moldova, Republic of;Netherlands;Romania
21NCT01759056
(ClinicalTrials.gov)
February 201324/12/2012Evaluation of an Oral Anti-TNF Antibody in Patients With Active Ulcerative ColitisA Multicenter, Double-Blind, Placebo-Controlled, Ascending-Dose, Repeat-Dose Safety and Pharmacokinetic Investigation of a Delayed-Release, Enteric-Coated Capsule Formulation of AVX 470 [Anti-TNF (Tumor Necrosis Factor) Globulin (Bovine)] in Patients With Active Ulcerative ColitisUlcerative ColitisDrug: AVX 470;Drug: PlaceboAvaxia Biologics, IncorporatedNULLCompleted18 Years75 YearsBoth33Phase 1United States;Belgium;Canada;Hungary
22NCT02922374
(ClinicalTrials.gov)
January 201328/9/2016Ulcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative ColitisUlcerative Colitis Endoscopic Index of Severity and Fecal Calprotectin to Predict the Reaction to Corticosteroids of Acute Severe Ulcerative Colitis: A Prospective Observational StudyAcute Severe Colitis (ASC)Drug: corticosteroidsJinling Hospital, ChinaNULLActive, not recruiting18 YearsN/ABoth117Phase 1/Phase 2China
23EUCTR2010-023798-20-ES
(EUCTR)
29/11/201210/05/2012A CLINICAL TRIAL WITH FAT-DERIVED ADULT STEM CELLS TO TREAT ULCERATIVE COLITISA PHASE I/IIA CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS (ASC) ON INDUCTION TO REMISSION IN ULCERATIVE COLITIS - ALOASCU
MedDRA version: 14.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: ASC
INN or Proposed INN: adipose tissue-derived mesenchymal stem cells
Other descriptive name: aloASC
Fundacion para la Investigacion Biomedica Hospital Universitario La PazNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 1/2Spain
24EUCTR2010-023494-19-SE
(EUCTR)
10/02/201127/12/2010A Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative ColitisA Phase IIa, Multi-Centre, Double-blind, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of K(D)PT after Multiple Ascending Doses in Patients with Active Mild to Moderate Ulcerative Colitis Ulcerative colitis
MedDRA version: 12.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: Lysine-D-Proline-Threonine
Product Code: K(D)PT
Dr. August Wolff GmbH & Co. KG ArzneimittelNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Sweden
25NCT01290042
(ClinicalTrials.gov)
February 201127/1/2011Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.A Phase 1, Randomized, Double-Blind, Placebo-controlled, Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects, in Subjects With Active Ulcerative Colitis, and in Subjects With Active Crohn's Disease.Ulcerative Colitis;Crohn's DiseaseDrug: AMG 181;Other: Placebo for AMG 181AmgenNULLCompleted18 Years65 YearsBoth43Phase 1United States;Australia
26NCT01164904
(ClinicalTrials.gov)
July 20101/7/2010Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisA Phase 1, Randomized, Double-blind, Placebo-controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative ColitisUlcerative ColitisDrug: Amg 181AmgenNULLTerminated18 Years55 YearsBoth72Phase 1United States;Australia;New Zealand
27NCT01149694
(ClinicalTrials.gov)
June 200922/6/2010A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy VolunteersA Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy VolunteersUlcerative ColitisDrug: PUR 0110 Rectal Enema or Placebo EnemaPurGenesis Technologies Inc.NULLCompleted18 Years55 YearsMale24Phase 1Germany
28EUCTR2006-001310-32-LT
(EUCTR)
17/07/200615/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
29EUCTR2006-001310-32-HU
(EUCTR)
29/06/200623/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
30EUCTR2006-001310-32-CZ
(EUCTR)
26/06/200617/05/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
31EUCTR2006-001310-32-EE
(EUCTR)
16/06/200627/04/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - ASCEND III Ulcerative Colitis
MedDRA version: 8.1;Classification code 10009900
Product Name: Asacol 800 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Product Name: Asacol 400 mg tablet
INN or Proposed INN: mesalazine
Other descriptive name: 5-aminosalicylic acid (5-ASA)
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
770Hungary;Czech Republic;Estonia;Latvia;Lithuania
32EUCTR2006-001310-32-LV
(EUCTR)
28/04/200622/08/2006A double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend IIIA double-blind, randomized, 6-week, parallel-group clinicaltrial to assess the safety and efficacy of Asacol 4.8 g/day(800 mg mesalamine tablet) versus Asacol 2.4 g/day (400 mgmesalamine tablet) for the treatment of moderately activeulcerative colitis (ASCEND III) - Ascend III Ulcerative ColitisProduct Name: Asacol 800mg tablet
INN or Proposed INN: mesalazine
Product Name: Asacol 400mg tablet
INN or Proposed INN: mesalazine
Procter & Gamble Technical Centres LimitedNULLNot RecruitingFemale: yes
Male: yes
470Hungary;Czech Republic;Estonia;Latvia;Lithuania
33NCT00577473
(ClinicalTrials.gov)
February 200119/12/2007Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)A Double-blind, Randomized, 6 Week, Parallel-group Design Clinical Trial in Patients With Mildly to Moderately Active Ulcerative Colitis to Assess the Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/DayUlcerative ColitisDrug: mesalamineWarner ChilcottNULLCompleted18 Years65 YearsAll301Phase 3United States