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Clinical trials for Collagenous 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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   43881   clinical trials with a EudraCT protocol, of which   7295   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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    8 result(s) found for: Collagenous Colitis. Displaying page 1 of 1.
    EudraCT Number: 2006-004159-39 Sponsor Protocol Number: BUC-60/COC Start Date*: 2007-03-15
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, double-dummy, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules vs. mesalazine granules vs. placebo for pat...
    Medical condition: Collagenous colitis
    Disease: Version SOC Term Classification Code Term Level
    14.0 10017947 - Gastrointestinal disorders 10048928 Colitis collagenous PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) LT (Completed) DK (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-001891-39 Sponsor Protocol Number: version4.6,29082018 Start Date*: 2018-09-14
    Sponsor Name:XiCoCo study group
    Full Title: Rifaximin-treatment of Collagenous colitis: A prospective, double-blind, placebo-controlled study
    Medical condition: Collagenous Colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10048928 Colitis collagenous LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2007-001315-31 Sponsor Protocol Number: BUC-63/COC Start Date*: 2008-03-13
    Sponsor Name:Dr. Falk Pharma GmbH
    Full Title: Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients w...
    Medical condition: Collagenous colitis
    Disease: Version SOC Term Classification Code Term Level
    8.1 10048928 Colitis collagenous LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) HU (Completed) DK (Completed) CZ (Completed) BE (Completed)
    Trial results: View results
    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: 2016-004216-36 Sponsor Protocol Number: BDPCC Start Date*: 2017-03-09
    Sponsor Name:I.R.C.C.S. POLICLINICO SAN DONATO
    Full Title: Pilot, open-label, spontaneous, Phase II study on the efficacy of beclomethasone dipropionate (BDP) for treatment of Collagenous colitis (CC)
    Medical condition: collagenous colitis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004856 10048928 Colitis collagenous LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (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: 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: (No results available)
    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
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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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