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Clinical trials for Microscopic Colitis AND Colitis

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    19 result(s) found for: Microscopic Colitis AND Colitis. Displaying page 1 of 1.
    EudraCT Number: 2009-017240-14 Sponsor Protocol Number: 2010/109 Start Date*: 2012-06-21
    Sponsor Name:ASOCIACIÓN GALLEGA DE ENFERMEDAD INFLAMATORIA INTESTITAL (E.I.G.A.)
    Full Title: EFFICACY OF BECOMETASONE DIPROPIONATE ON MICROSCOPIC COLITIS
    Medical condition: Microscopic colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10056979 Colitis microscopic PT
    14.1 10017947 - Gastrointestinal disorders 10048928 Colitis collagenous LLT
    14.1 10017947 - Gastrointestinal disorders 10025268 Lymphocytic colitis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-001912-31 Sponsor Protocol Number: BUG-3/MIC Start Date*: 2014-02-19
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Randomised, double-blind, placebo-controlled, multi-centre trial on the efficacy and safety of budesonide for induction of remission in incomplete microscopic colitis
    Medical condition: Patients with active incomplete microscopic colitis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10017947 - Gastrointestinal disorders 10056979 Colitis microscopic PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) ES (Completed) SE (Completed) NL (Prematurely Ended) DK (Completed) LT (Completed) PT (Completed) AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020448-37 Sponsor Protocol Number: ENC-0303-CL-203 Start Date*: 2011-12-21
    Sponsor Name:Enceladus Pharmaceuticals
    Full Title: 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 ...
    Medical condition: Active Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10017947 - Gastrointestinal disorders 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001893-32 Sponsor Protocol Number: GLPG1205-CL-211 Start Date*: 2015-01-19
    Sponsor Name:Galapagos NV
    Full Title: Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients with Moderate to Severe U...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Completed) BE (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-003604-19 Sponsor Protocol Number: IM101108 Start Date*: 2007-08-06
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase III, Multi-Center, Randomized, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of Induction and Maintenance Therapy with Abatacept in Subjects with Active Ulcerative C...
    Medical condition: ULCERATIVE COLITIS,NOS
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Completed) IE (Prematurely Ended) BE (Completed) GB (Prematurely Ended) CZ (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2012-005521-73 Sponsor Protocol Number: GLPG0974-CL-201 Start Date*: 2013-03-20
    Sponsor Name:Galapagos NV
    Full Title: Exploratory, Phase II, Randomized, Double-blind, Placebo-controlled, Proof-of-Concept study to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of GLPG0974 in sub...
    Medical condition: Mild to moderate Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    16.0 10017947 - Gastrointestinal disorders 10009900 Colitis ulcerative PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) CZ (Completed) LV (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2019-002762-12 Sponsor Protocol Number: SJ-674 Start Date*: 2021-12-07
    Sponsor Name:Zealand University Hospital
    Full Title: The prevalence of bile acid diarrhéa and the effect of budesonid on the bile acid homeostasis in patients with microscopic colitis
    Medical condition: Microscopic colitis Bile acid diarrhea
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2004-003880-61 Sponsor Protocol Number: 060-CL-305 Start Date*: 2005-02-08
    Sponsor Name:Yamanouchi Europe B.V.
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE POTENTIAL EFFICACY, SAFETY AND TOLERABILITY OF DIFFERENT ORAL DOSES OF YM060 IN PATIENTS WITH DIARRHEA-PREDOMINANT IRRITABLE ...
    Medical condition: diarrhea-predominant irritable bowel syndrome
    Disease: Version SOC Term Classification Code Term Level
    10023003
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) EE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2017-003703-22 Sponsor Protocol Number: P2-IMU-838-UC Start Date*: 2018-05-03
    Sponsor Name:Immunic AG
    Full Title: A phase 2, multicenter, randomized, double-blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of IMU 838 for induction and maintenance therapy in moderate-to-severe u...
    Medical condition: Ulcerative Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10045365 Ulcerative colitis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Prematurely Ended) NL (Completed) PL (Completed) PT (Completed) HR (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2019-000245-12 Sponsor Protocol Number: Repha_1436 Start Date*: 2020-01-20
    Sponsor Name:Repha GmbH
    Full Title: Controlled clinical trial to evaluate the efficacy and safety of MYRRHINIL-INTEST® versus placebo in patients with diarrhea-dominant irritable bowel syndrome (IBS-D) and patients with mixed-type ir...
    Medical condition: A confirmed diagnosis of irritable bowel syndrome (IBS-D or IBS-M) by a specialist in gastroenterology and/or internal medicine and/or general medicine
    Disease: Version SOC Term Classification Code Term Level
    20.0 10017947 - Gastrointestinal disorders 10023002 Irritable bowel LLT
    26.0 10017947 - Gastrointestinal disorders 10060845 Diarrhea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-018340-14 Sponsor Protocol Number: 10085 Start Date*: 2010-11-25
    Sponsor Name:University of Nottingham
    Full Title: Efficacy and mode of action of mesalazine in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D).
    Medical condition: Diarrhoea-predominant irritable bowel syndrome
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10060849 Diarrhoea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002678-31 Sponsor Protocol Number: CA184-007 Start Date*: 2006-03-20
    Sponsor Name:BRISTOL-M.SQUIBB
    Full Title: Randomized, double-blind, placebo controlled phase II study comparing the safety of MDX-010 BMS-734016 administered with or without prophylactic oral budesonide Entocort EC in patients with unr...
    Medical condition: Melanoma
    Disease: Version SOC Term Classification Code Term Level
    6.1 10027156 HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-004063-36 Sponsor Protocol Number: CELIM-RCD-002 Start Date*: 2016-02-22
    Sponsor Name:Celimmune LLC
    Full Title: A Phase 2a, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of AMG 714 in Adult Patients with Type II Refractory Celiac Disease, an In Situ Sm...
    Medical condition: Type II Refractory Celiac Disease (RCD-II)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FI (Completed) NL (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2013-002924-17 Sponsor Protocol Number: A3384-001 Start Date*: 2014-01-27
    Sponsor Name:Albireo AB
    Full Title: A double-blind, randomized, placebo-controlled, study to demonstrate the efficacy and safety of 250 mg or 1 g A3384 administered orally twice daily for two weeks to patients with Bile Acid Malabsor...
    Medical condition: Patients with Bile Acid Malabsorption (BAM)/Bile Acid Diarrhoea (BAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002394-22 Sponsor Protocol Number: RFIB3053 Start Date*: 2013-09-26
    Sponsor Name:Salix Pharmaceuticals, Inc.
    Full Title: A Study to Assess Repeat Treatment Efficacy and Safety of Rifaximin 550 mg TID in Subjects with Irritable Bowel Syndrome with Diarrhoea (IBS-D)
    Medical condition: Irritable bowel syndrome (IBS) is a heterogeneous gastrointestinal (GI) disorder characterized by frequent and debilitating symptoms (e.g. diarrhoea, bloating, abdominal pain, urgency to defecate, ...
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004856 10060849 Diarrhoea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-003064-38 Sponsor Protocol Number: E7046-G000-102 Start Date*: 2017-06-12
    Sponsor Name:Adlai Nortye USA Inc
    Full Title: An Open-Label Multicenter Phase 1b Study of E7046 in Combination With Radiotherapy/Chemoradiotherapy (RT/CRT) in Preoperative Treatment of Subjects With Rectum Cancer
    Medical condition: locally advanced rectum cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007464 Carcinoma rectum LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-000895-14 Sponsor Protocol Number: NAK-07 Start Date*: 2014-01-27
    Sponsor Name:Menarini Ricerche S.p.A.
    Full Title: A 52-week, double-blind, randomised, placebo-controlled, parallel-group phase III study with re-randomisation at week 25 to evaluate the efficacy and safety of oral ibodutant 10 mg once daily in f...
    Medical condition: Irritable bowel syndrome with diarrhoea (IBS-D) in female patients.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004856 10060849 Diarrhoea predominant irritable bowel syndrome LLT
    18.0 100000004856 10060845 Diarrhea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: HU (Prematurely Ended) SE (Prematurely Ended) LV (Prematurely Ended) CZ (Prematurely Ended) SK (Prematurely Ended) DE (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-000533-31 Sponsor Protocol Number: 17GA001 Start Date*: 2017-11-07
    Sponsor Name:Nottingham University Hospitals NHS Trust
    Full Title: TReatment of Irritable bowel syndrome using Titrated ONdansetron Trial
    Medical condition: Irritable Bowel Syndrome with Diarrhoea
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10060845 Diarrhea predominant irritable bowel syndrome LLT
    21.1 100000004856 10060849 Diarrhoea predominant irritable bowel syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-001892-30 Sponsor Protocol Number: GLPG1205-CL-201 Start Date*: 2014-12-08
    Sponsor Name:Galapagos NV
    Full Title: Phase II, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GLPG1205 in Patients With Moderate Crohn’s Dis...
    Medical condition: Crohn’s Disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10017947 - Gastrointestinal disorders 10011401 Crohn's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) BE (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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