97. 潰瘍性大腸炎 Ulcerative colitis Clinical trials / Disease details


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

  
16 trials found
No.TrialIDDate_
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PhaseCountries
1NCT05341401
(ClinicalTrials.gov)
June 202221/3/2022Budesonide Multimatrix(MMX) Versus Prednisolone in Management of Mild to Moderate Ulcerative ColitisBudesonide MMX Versus Prednisolone in Management of Mild to Moderate Ulcerative ColitisUlcerative Colitis ChronicDrug: Budesonide MMX;Drug: PrednisoloneAssiut UniversityNULLNot yet recruiting18 Years60 YearsAll100Phase 2/Phase 3NULL
2JPRN-UMIN000030000
2018/02/0701/12/2017The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis.The efficacy and safety of topical budezonide for pouchitis after restorative proctocolectomy in patients with ulcerative colitis. - The efficacy and safety of topical budezonide for pouchitis. ulcerative colitispouchitisTopical budesonido
2weeks of 2mg daily
Topical prednisolone
2weeks 20mg daily
Topical aminosalicylate
2weeks 1g daily
Department of Inflammatory Bowel DiseaseHyogo College of MedicineNULLComplete: follow-up completeNot applicableNot applicableMale and Female30Phase 1Japan
3NCT02425852
(ClinicalTrials.gov)
December 201621/4/2015A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe ColitisA Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus Infliximab to Corticosteroids Plus Azathioprine for Acute Severe ColitisUlcerative ColitisDrug: Azathioprine;Drug: Infliximab;Drug: Prednisolone;Drug: HydrocortisoneGroupe d'Etude Therapeutique des Affections Inflammatoires DigestivesNULLRecruiting18 YearsN/AAll146Phase 4France
4EUCTR2010-020448-37-NL
(EUCTR)
21/12/201116/09/2010Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. Active Ulcerative Colitis
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: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Enceladus PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Belgium;Netherlands
5JPRN-UMIN000005358
2011/04/0101/04/2011Rapid LeukocyAPheresis InDuction for Ulcerative ColitisRapid LeukocyAPheresis InDuction for Ulcerative Colitis - RAPID-UC ulcerative colitisLCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 3 days.
LCAP is determined to apply if patient does not obtain a significant improvement (higher than 50%) in spite of recieving sufficient steroid therapy (higher than 30mg/day of prednisolone) for 14 days.
Lower Gastroenterology, Hyogo College of MedicineDepartment of Gastroenterology, Osaka City University and Department of Gastroenterology, Osaka Medical CollegeComplete: follow-up complete12years-old81years-oldMale and Female40Phase 2,3Japan
6EUCTR2010-020448-37-BE
(EUCTR)
10/12/201022/12/2010Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis.Randomized placebo-controlled multicenter exploratory Phase IIA study to assess the safety and efficacy of PEG-liposomal prednisolone sodium phosphate (Nanocort) in subjects with active ulcerative colitis. Active Ulcerative Colitis
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: PEG-liposomal prednisolone sodium phosphate
Product Code: Nanocort
INN or Proposed INN: Prednisolone Sodium Phosphate
Other descriptive name: PREDNISOLONE SODIUM PHOSPHATE
Enceladus PharmaceuticalsNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Belgium;Netherlands
7NCT00984568
(ClinicalTrials.gov)
November 200924/9/2009Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)Conventional Step-Up Versus Infliximab Monotherapy in Patients With Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter StudyColitis, UlcerativeBiological: Infliximab;Drug: Prednisolone;Drug: 5-aminosalicylic acid;Drug: AzathioprineMerck Sharp & Dohme Corp.NULLTerminated18 YearsN/AAll28Phase 3Germany
8EUCTR2009-010065-23-DE
(EUCTR)
17/08/200914/04/2009Conventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIXConventional Step-Up versus Infliximab Monotherapy in Patients with Active Moderate to Severe Ulcerative Colitis. A Randomized, Open Label, Prospective, Multicenter Study (Phase 3, Protocol No. P05553) - MUNIX Active Moderate to Severe Ulcerative Colitis
MedDRA version: 14.1;Level: LLT;Classification code 10066678;Term: Acute ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Classification code 10033007;Term: Other ulcerative colitis;Classification code 10045366;Term: Ulcerative colitis, unspecified;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 10017947 - Gastrointestinal disorders
Trade Name: Remicade
INN or Proposed INN: infliximab
Other descriptive name: 100
Trade Name: Pentasa 500 mg Retardtabletten
Product Name: 5-Aminosalicylic acid (5-ASA)
INN or Proposed INN: 5-Aminosalicylic acid
Trade Name: Imurek 25mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Imurek 50mg Filmtabletten
INN or Proposed INN: azathioprine
Trade Name: Decortin H 1 mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 5mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 10mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 20mg
INN or Proposed INN: prednisolone
Trade Name: Decortin H 50 mg
INN or Proposed INN: prednisolone
Essex Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 3Germany
9EUCTR2004-005032-35-BE
(EUCTR)
06/03/200723/11/2006A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Italy;Sweden
10EUCTR2004-005032-35-IT
(EUCTR)
10/05/200619/01/2007A Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative ColitisA Phase III, Multicentre, Pan-European, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of Targeted Release Prednisolone in Treatment of Moderate, Acute Ulcerative Colitis Ulcerative colitis
MedDRA version: 9.1;Level: LLT;Classification code 10009900;Term: Colitis ulcerative
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Product Name: COLAL PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone
Trade Name: PREDNISOLONE
INN or Proposed INN: Prednisolone
ALIZYMENULLNot RecruitingFemale: yes
Male: yes
890Phase 3Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
11NCT00299013
(ClinicalTrials.gov)
March 20062/3/2006Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative ColitisA Multicentre, Randomised, Double Blind, Double Dummy, Active Comparator Controlled, Parallel Group Study of COLAL-PRED® in the Treatment of Moderate Acute Ulcerative ColitisUlcerative ColitisDrug: COLAL-PRED®;Drug: PrednisoloneAlizymeNULLCompleted18 Years75 YearsBoth796Phase 3Australia;Belgium;Czech Republic;Denmark;France;Germany;Hungary;Israel;Italy;Poland;Russian Federation;South Africa;Spain;Sweden;United Kingdom
12EUCTR2004-005032-35-SE
(EUCTR)
17/11/200514/09/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
13EUCTR2004-005032-35-CZ
(EUCTR)
04/11/200516/09/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Italy;Sweden
14EUCTR2004-005032-35-DK
(EUCTR)
24/10/200504/10/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
15EUCTR2004-005032-35-HU
(EUCTR)
24/10/200522/09/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Trade Name: Prednisolone
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot RecruitingFemale: yes
Male: yes
890Hungary;Czech Republic;United Kingdom;Belgium;Denmark;Spain;Italy;Sweden
16EUCTR2004-005032-35-GB
(EUCTR)
11/10/200524/02/2005A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis.A Multicentre, Randomised, Double-Blind, Double-Dummy, Active Comparator Controlled, Parallel Group Study of COLAL PRED® in the Treatment of Moderate Acute Ulcerative Colitis. Moderate acute ulcerative colitis.Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Trade Name: Prednisolone Tablets B.P. 5mg
Product Name: Prednisolone
INN or Proposed INN: Prednisolone
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Product Name: COLAL-PRED
Product Code: ATL-2502
INN or Proposed INN: Prednisolone sodium metasulphobenzoate
Alizyme Therapeutics LimitedNULLNot Recruiting Female: yes
Male: yes
890 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Czech Republic;Belgium;Spain;Denmark;Italy;United Kingdom;Sweden