Enema ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
97Ulcerative colitis38

97. Ulcerative colitis


Clinical trials : 2,527 Drugs : 1,465 - (DrugBank : 259) / Drug target genes : 144 - Drug target pathways : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCTs031210326
21/09/202121/09/2021Evaluation of biomarkers in BF treatmentA multicenter study to evaluate the effectiveness of budesonide enema foam treatment and the usefulness ofserum biomarker measurement for active ulcerative colitis - BF-LRG Ulcerative colitis
Ulcerative colitis
Budesonide foam was administered as a study drugMatsuoka KatsuyoshiEA Pharma Co., Ltd.Recruiting>= 16age oldNot applicableBoth20N/AJapan
2EUCTR2021-003023-14-SE
(EUCTR)
02/09/202123/06/2021Pharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative ColitisPharmacokinetics of Cobitolimod Enemas in Participants with active Ulcerative Colitis Moderate to Severe Active 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 Code: DIMS0150
INN or Proposed INN: Cobitolimod
Other descriptive name: DIMS0150
InDex Pharmaceuticals ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 1;Phase 2Sweden
3EUCTR2020-000609-10-DK
(EUCTR)
06/07/202123/09/2020A combination of immunesystem stimulating- and antibiotic treatment for inflammation of the pouch in ulcerative colitis patientsA combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgeryA clinical safety and proof-of-concept study A combination of GM-CSF and metronidazole/fosfomycin treatment for pouchitis in Ulcerative Colitis patients after ileal-pouch-anal anastomosis surgery given as an enema or spray in the pouch.
MedDRA version: 20.0;Level: PT;Classification code 10036463;Term: Pouchitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: Repomol
INN or Proposed INN: Molgramostim
Trade Name: Metronidazole
Product Name: Metronidazole
INN or Proposed INN: METRONIDAZOLE
Other descriptive name: Metronidazole
Trade Name: Fosfomycin
Product Name: Infectofos
INN or Proposed INN: Fosfomycin disodium
Other descriptive name: FOSFOMYCIN DISODIUM
Center for Surgical ScienceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
26Phase 1;Phase 2Denmark
4ChiCTR2000039161
2020-10-302020-10-20Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child-bearing female with active ulcerative colitis: a randomized, double-blind, controlled trialA systematic study on the criteria of syndrome differentiation of kidney Yang deficiency in infertility Ulcerative colitiscontrol group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;Chengdu University of Traditional Chinese MedicineNULLRecruiting2045Femalecontrol group:118;experimental group:118;China
5ChiCTR2000038888
2020-10-192020-10-09Effect of Kangfuxin Liquid enema combined with mesalazine on gestational outcomes and quality of life in child -bearing female with active ulcerative colitis: a randomized, double-blind, controlled trialA systematic study on the criteria of syndrome differentiation of kidney yang deficiency in infertility Ulcerative colitiscontrol group:Mesalazine enteric-coated tablets + placebo enema;experimental group:Mesalazine enteric-coated tablets +Kangfuxin Liquid enema;Chengdu University of Traditional Chinese MedicineNULLRecruiting2045Femalecontrol group:118;experimental group:118;China
6NCT04202211
(ClinicalTrials.gov)
February 202013/12/2019FMT for Remission of Active Ulcerative Colitis in AdultsA Randomized Double-blind, Placebo-controlled Trial of Lyophilized Fecal Microbiota Transplantation for the Induction of Remission in Adults With Active Ulcerative ColitisUlcerative Colitis;Inflammatory Bowel DiseasesBiological: FMT oral;Biological: FMT enema;Other: Placebo oral;Other: Placebo enemaUniversity of British ColumbiaCrohn's and Colitis Canada;Vancouver Island Health AuthorityNot yet recruiting18 YearsN/AAll145Phase 2Canada
7ChiCTR1900025900
2019-12-012019-09-13Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial.Efficacy of Herbal enema prescriptionII(DHEP II) in the treatment of mild or moderate active symptoms of ulcerative colitis:A multicenter prospective randomized control clinical trial. Ulcerative colitisExperimental group:Mesalazine+DHEP II;control group:Mesalazine+Compound Huangbai lotion;Nanjing Hospital of Chinese MedicineNULLPendingBothExperimental group:200;control group:100;Phase 3China
8NCT03917095
(ClinicalTrials.gov)
May 15, 201912/4/2019The Safety and Efficacy of TET Enema in the Treatment of UCMesalazine and Compound Glutamin Enema for the Treatment of Ulcerative Colitis Through Colonic Transendoscopic Enteral Tubing: A Multicenter, Randomized, Controlled TrailUlcerative Colitis Chronic Mild;Ulcerative Colitis Chronic ModerateDevice: The Colonic Transendoscopic enteral Tubing.;Drug: Glutamine;Drug: MesalazineThe Second Hospital of Nanjing Medical UniversityNULLRecruiting18 Years65 YearsAll75N/AChina
9JPRN-UMIN000034016
2018/12/0103/09/2018The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled studyThe investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study - STABILITY study ulcerative colitisAdditional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema
The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)
Hyogo College of MedicineNULLComplete: follow-up complete16years-oldNot applicableMale and Female84Not selectedJapan
10NCT03521232
(ClinicalTrials.gov)
May 15, 201817/4/2018A Study of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative ProctosigmoiditisA Phase I/IIA, Open-Label, Three-Stage Study to Investigate the Safety, the Efficacy and the Pharmacokinetics of Niclosamide Enemas in Subjects With Active Ulcerative Proctitis or Ulcerative Procto-SigmoiditisUlcerative Colitis;Ulcerative Proctitis;Ulcerative ProctosigmoiditisDrug: NiclosamideFirst Wave Bio, Inc.NULLRecruiting18 YearsN/AAll56Phase 1/Phase 2Italy
11NCT03104036
(ClinicalTrials.gov)
June 19, 201727/3/2017Faecal Bacteriotherapy for Ulcerative ColitisFaecal Bacteriotherapy for Ulcerative ColitisUlcerative ColitisOther: Faecal bacterial transplantation;Drug: Mesalazine 4G EnemaInstitute for Clinical and Experimental MedicineInstitute of Animal Physiology and Genetics Academy of Science Czech RepublicCompleted18 Years70 YearsAll61Phase 2Czechia;Czech Republic
12NCT03110198
(ClinicalTrials.gov)
May 201719/2/2017Mesalazine With Hydrocortisone Sodium Succinate Enema for 4-Week Treatment in Patients With Ulcerative ColitisA Randomized, Double-blind Study Investigating the Efficacy and Safety of Mesalazine With Hydrocortisone Sodium Succinate (100mg QD) Enema for 4-Week Treatment in Patients With Ulcerative Colitis (UC)Ulcerative Colitis, UnspecifiedDrug: Mesalazine;Drug: hydrocortisone sodium succinate;Drug: Mesalazine with hydrocortisone sodium succinateXijing Hospital of Digestive DiseasesShanghai Tongji Hospital, Tongji University School of Medicine;First Affiliated Hospital of Zhongshan Medical UniversityRecruiting18 Years70 YearsAll528Phase 4China
13NCT02487238
(ClinicalTrials.gov)
November 201525/6/2015Pediatric FEcal Microbiota Transplant for Ulcerative ColitisA Single-Blind, Randomized, Placebo-Controlled Trial of Human Fecal Microbiota Transplantation for the Therapy of Pediatric Ulcerative Colitis and Inflammatory Bowel Disease UnclassifiedInflammatory Bowel Disease;Ulcerative ColitisBiological: Fecal Microbiota Enema;Biological: Normal Saline EnemaMcMaster Children's HospitalLondon Health Sciences Centre;St. Justine's HospitalCompleted3 Years17 YearsAll35Phase 1Canada
14NCT04434872
(ClinicalTrials.gov)
July 201528/5/2015Fecal Microbiota Transplantation as a Treatment for Ulcerative ColitisUlcerative ColitisProcedure: Colonoscopy;Procedure: Gastroscopy;Drug: Fecal Microbiota;Procedure: EnemaTel-Aviv Sourasky Medical CenterNULLTerminated18 Years70 YearsAll80Phase 2Israel
15NCT02368717
(ClinicalTrials.gov)
March 201516/2/2015An Efficacy and Safety Study of PENTASA in Chinese Patients With Left-sided Active Ulcerative Colitis Followed by a 24-Week Open-Label Extension PhaseA Randomized, Double-blind, Placebo-controlled, Multi-centre, Superiority Study Investigating the Efficacy and Safety of PENTASA Enema Compared With Placebo Enema for 4-Week Treatment in Chinese Patients With Left-sided Active Ulcerative Colitis (UC) Followed by a Maximal 28-Week Open-Label Extension Phase of PENTASA Enema and/or PENTASA TabletsUlcerative ColitisDrug: Mesalazine Enema;Drug: Placebo EnemaFerring PharmaceuticalsNULLCompleted18 Years70 YearsAll281Phase 3China
16EUCTR2013-004599-36-DE
(EUCTR)
23/04/201403/02/2014SB012 for the treatment of active ulcerative colitis: a clinical study in early development (phase IIa), conducted in several study centres, with random assignment of patients to active treatment or placebo, to investigate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once dailySB012 for the treatment of active ulcerative colitis (SECURE): a prospective, multi-centre, randomised, double-blind, placebo-controlled phase IIa clinical trial to evaluate the efficacy, pharmacokinetics, tolerability, and safety of SB012 enema administered once daily - SECURE Active ulcerative colitis;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]Product Name: SB012
INN or Proposed INN: hgd40
sterna biologicals GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
17NCT02129439
(ClinicalTrials.gov)
April 201430/4/2014Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis PatientsSB012 for Treatment of Active Ulcerative Colitis: Prospective Multi-centre Randomised Double-blind Placebo-controlled Phase IIa Clinical Trial to Evaluate Efficacy, Pharmacokinetics, Tolerability and Safety of SB012 Enema Administered ODColitis, UlcerativeDrug: SB012;Drug: PlaceboSterna Biologicals GmbH & Co. KGNULLCompleted18 Years75 YearsAll20Phase 1/Phase 2Germany
18NCT01586533
(ClinicalTrials.gov)
June 201225/4/2012Study of the Safety and Efficacy of Zoenasa® Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisA Phase II Double-blind, Randomized, Comparator-controlled Study of the Safety and Efficacy of Zoenasa™ Rectal Gel (Mesalamine Plus N-acetylcysteine) in Subjects With Left-sided Ulcerative ColitisUlcerative Colitis;Left-sided Ulcerative Colitis;Distal Ulcerative ColitisDrug: Zoenasa-1:4;Drug: Mesalamine EnemaAltheus Therapeutics, Inc.NULLActive, not recruiting18 Years64 YearsBoth120Phase 2United States
19NCT01149707
(ClinicalTrials.gov)
June 1, 201022/6/2010Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative ColitisA 2-Week Exploratory Randomized, Double-Blind, Parallel-Group, Dose-Ranging, Placebo-Controlled Safety, Tolerability, Biomarker and Efficacy Clinical Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative ColitisLeft-Sided Ulcerative Colitis;ProctosigmoiditisDrug: PUR 0110 Rectal Enema 250 mg;Drug: PUR 0110 Rectal Enema 500 mg;Drug: PUR 0110 Rectal Enema 1000 mg;Drug: Placebo EnemaPurGenesis Technologies Inc.NULLCompleted18 Years75 YearsAll34Phase 2Germany
20EUCTR2009-017839-18-DE
(EUCTR)
14/05/201016/02/2010A 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITISA 2-WEEK EXPLORATORY RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, DOSE-RANGING, PLACEBO-CONTROLLED SAFETY, TOLERABILITY, BIOMARKER AND EFFICACY CLINICAL STUDY OF PUR 0110 RECTAL ENEMA IN MILD-TO-MODERATE DISTAL ULCERATIVE COLITIS Active mild-to-moderate distal ulcerative colitis
MedDRA version: 13.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
Product Name: PUR 0110
Product Code: PUR 0110
Other descriptive name: PCT (PureCell Technologies Complex)
PurGenesis Techonologies Inc.NULLNot RecruitingFemale: yes
Male: yes
56Germany
21NCT04753775
(ClinicalTrials.gov)
March 10, 20109/2/2021RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)Drug: Aloe vera gelOspedale Sandro Pertini, RomaNULLCompleted18 YearsN/AAll44N/ANULL
22NCT01020708
(ClinicalTrials.gov)
November 200920/11/2009Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative ColitisA Phase I Double-blind, Randomized, Comparator-controlled Study of the Safety and Tolerability of N-acetylcysteine Plus Mesalamine Enema in Subjects With Left-sided Ulcerative ColitisUlcerative ColitisDrug: mesalamine;Drug: ALTH12-1:4;Drug: ALTH12-2:4Altheus Therapeutics, Inc.NULLCompleted18 Years64 YearsBoth9Phase 1United States
23NCT01149694
(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
24JPRN-UMIN000008967
2009/01/0124/09/2012Efficacy of zinc-carnosine chelate compound, Polaprezinc, enemas in patients with ulcerative colitis Ulcerative ColitisPolaprezinc group: Polaprezinc enema contained 150 mg of Polaprezinc suspension in tap water (total volume 100 mL) daily for one week

Placebo group: 100 mL tap water enema daily for one week
The Jikei University School of MedicineDivision of Gastroenterology and HepatologyNULLComplete: follow-up complete18years-oldNot applicableMale and Female30Not applicableJapan
25EUCTR2008-000967-40-NL
(EUCTR)
03/11/200830/05/2008A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative ColitisA Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
ActoGeniX NV.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Netherlands;Belgium;Sweden
26NCT00737789
(ClinicalTrials.gov)
November 200819/8/2008Mesalazine 4g Once Daily Versus 4g in Two Divided Doses in Active Ulcerative Colitis.Multicentre, Controlled, Randomised, Investigator-Blinded, Comparative Study of Oral Mesalazine 4g Once Daily Versus Mesalazine 4g in Two Divided Doses in Patients With Active Ulcerative Colitis.Ulcerative ColitisDrug: Mesalazine slow-release granules;Drug: Mesalazine liquid enemaFerring PharmaceuticalsNULLCompleted18 YearsN/ABoth206Phase 3Belgium;France;Netherlands;United Kingdom
27EUCTR2008-000967-40-SE
(EUCTR)
29/08/200804/06/2008A Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative ColitisA Phase 2a Randomised, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderatley Active Ulcerative Colitis Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
ActoGeniX NV.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Netherlands;Belgium;Sweden
28EUCTR2008-000967-40-BE
(EUCTR)
13/06/200805/08/2008A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative ColitisA Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects with Moderately Active Ulcerative Colitis Moderately Active Ulcerative Colitis
MedDRA version: 9.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Enema
Product Code: AG011
Product Name: AG011 - Capsules
Product Code: AG011
ActoGeniX N.VNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Netherlands;Belgium;Sweden
29EUCTR2007-007702-30-IT
(EUCTR)
03/04/200808/07/2008Feasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - NDFeasibility and safety of Infliximab enema treatment in patients with active left-sided ulcerative colitis. An open-label, non comparative, pilot study. - ND Ulcerative colitis
MedDRA version: 9.1;Level: SOC;Classification code 10017947;Term: Gastrointestinal disorders
Trade Name: REMICADE
INN or Proposed INN: INFLIXIMAB
COSMO TECHNOLOGIES LTDNULLNot RecruitingFemale: no
Male: yes
Italy
30JPRN-JapicCTI-070399
22/6/200721/05/2007An Exploratory Study of Rebamipide in Patients With Active Ulcerative ColitisAn Exploratory Study of Rebamipide in Patients With Active Ulcerative Colitis Active ulcerative colitisIntervention name : Rebamipide
INN of the intervention : Rebamipide
Dosage And administration of the intervention : Intracolonial (enema)
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Intracolonial (enema)
Otsuka Pharmaceutical Co., Ltd.NULLcomplete16BOTH120Phase 2Japan
31EUCTR2006-004162-13-DE
(EUCTR)
27/02/200706/10/2006Randomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patientsRandomized, double-blind, placebo-controlled phase II pilot study of the impact of mesalazine enemas on the mucosal gut flora in patients with inflammatory bowel disease - Impact of mesalazine vs placebo on mucosal gut flora in IBD patients Active inflammatory bowel disease, i.e. either left-sided ulcerative colitis or Crohn´s Disease (Colon) with signs of inflammation within 40 cm ab ano.
MedDRA version: 8.1;Level: LLT;Classification code 10021972;Term: Inflammatory bowel disease
Trade Name: Salofalk 4g/60ml Klysma
INN or Proposed INN: MESALAZINE
Charité Universitätsmedizin, Campus Charité MitteNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Germany
32EUCTR2006-002036-25-GB
(EUCTR)
09/11/200615/02/2012Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UCEpidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UC Ulcerative ColitisProduct Name: Epidermal growth factor enema
Product Code: EGF enema
INN or Proposed INN: Epidermal growth factor
Trade Name: Pentasa enema
Product Name: Pentasa
INN or Proposed INN: mesalazine enema
University Hospitals of Leicester NHS TrustNULLNot RecruitingFemale: yes
Male: yes
50Phase 3United Kingdom
33ChiCTR-TRC-08000048
2006-10-012008-01-17A multicenter, double-blind, randomized controlled trial: Traditional Chinese Medicine treatment for ulcerative colitisIntervention and efficacy evaluation study of Traditional Chinese Medicine for ulcerative colitis Ulcerative colitisControlled group:Take mesalazine 1g Qid in active stage. Sustain the treatment for another week after the symptoms relieve. Then take 0.5g Tid and adjust the dosage according to the condition. The treatment lasts for 6 months.;Experimental group:Take the intestine-clearing and dissipating dampness formula 2 times a day in the 1st stage. Enema is given once a day for 12 days. Take health-supporting and intestine-clearing formula for spleen and stomach deficiency 2 times a day. The treatment lasts for 6 months;The Affiliated Hospital of Nanjing University of Traditional Chinese MedicineNULLCompleted1865BothControlled group:112;Experimental group:112;I (Phase 1 study)China
34NCT00269438
(ClinicalTrials.gov)
December 200522/12/2005New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative ColitisPhase 3 Study to Establish the Efficacy and Safety of a New Tablet Formulation and Dosing Regimen of Balsalazide Disodium Dosed Twice Daily in Achieving Clinical Improvement in Subjects With Mildly to Moderately Active Ulcerative Colitis After 8 Weeks of TherapyUlcerative ColitisDrug: 5 ASA, enemas, suppositories, corticosteroidsBausch Health Americas, Inc.NULLCompleted18 Years80 YearsAll225Phase 3United States
35EUCTR2004-000733-12-CZ
(EUCTR)
14/07/200401/07/2004A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis.A phase III, randomized, multi-center, double-blind, parallel-group, placebo controlled study to evaluate the safety and efficacy of SPD476 (mesalazine) given twice daily (2.4g/day) versus SPD476 given as a single dose (4.8g/day) in subject with acute mild to moderate ulcerative colitis. Subjects who have newly diagnosed or have a diagnosis of relapsing (relapses1 and a Physician Global Assessment of <2). The original diagnosis of UC must be established by sigmoidoscopy, colonoscopy, or barium enema and have compatible histology.Product Name: Mesalazine
Product Code: SPD476
INN or Proposed INN: Mesalazinum
Other descriptive name: 5-amino salicylic acid (5-ASA)
Shire Pharmaceutical Development IncNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Czech Republic
36NCT00063414
(ClinicalTrials.gov)
September 200325/6/2003ISIS 2302-CS22, A 6-Week, Active-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative ColitisISIS 2302-CS22, Phase II, Double-Blinded, Active-Controlled Study of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative Colitis (Left-Sided Colitis or Pancolitis With Left Sided Disease Flare)Ulcerative ColitisDrug: AlicaforsenIsis PharmaceuticalsNULLCompleted18 YearsN/ABothPhase 2United States
37NCT00063830
(ClinicalTrials.gov)
June 20037/7/2003ISIS 2302-CS27, A 6-Week, Placebo-Controlled Clinical Study to Evaluate the Effectiveness of Alicaforsen (ISIS 2302) in Patients With Mild to Moderate Active Ulcerative Colitis.ISIS 2302-CS27, Phase 2, Double-Blinded, Controlled Study of Four Dosing Regimens of Alicaforsen (ISIS 2302) Enema, an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Mild to Moderate Active Ulcerative ColitisUlcerative ColitisDrug: AlicaforsenIsis PharmaceuticalsNULLCompleted18 YearsN/ABothPhase 2United States
38NCT00061282
(ClinicalTrials.gov)
September 30, 200223/5/2003Clotrimazole Enemas for Pouchitis in Children and AdultsClotrimazole Enemas for Pouchitis in Children and AdultsUlcerative Colitis;Pouchitis;Ileitis;Inflammatory Bowel DiseaseDrug: ClotrimazolePaul RufoNULLTerminated2 YearsN/AAll18Phase 1/Phase 2United States