Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease (COBAM)
This study has been terminated.
Information provided by (Responsible Party):
Florian Beigel, Klinikum der Universitaet Muenchen, Grosshadern
First received: September 15, 2010
Last updated: April 17, 2013
Last verified: April 2013
The purpose of this study is to assess the efficacy of cholestagel to reduce the frequency of soft and liquid stools per day in patients with CD in clinical remission with symptoms of BAM and to assess the improvement in stool consistency and quality of life in these patients and to assess the safety of cholestagel.
Bile Acid Malabsorption
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
||Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
Primary Outcome Measures:
- Reduction of fluid stool > 30 % [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Improvement of Stool Consistency [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
Proportion of patients on cholestagel compared to placebo that reaches improvement of stool consistency on the Bristol stool chart of at least one point.
- Improvement of Quality of Life. [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
Proportion of patients on cholestagel compared to placebo that reaches an improvement of the Quality of Life.
- Change of median liquid or soft stool frequency/per day. [ Time Frame: 4 weeks after baseline ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2013 (Final data collection date for primary outcome measure)
Placebo Comparator: Placebo
Placebo tablet: 3 times daily 2 tablets
Active Comparator: Cholestagel
Colesevelam 625 mg tablet; 3 times daily 2 tablets
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Allergy or hypersensitivity to any of the components of cholestagel or placebo as identified from the medical history
- Participation at another clinical trial within a period of 4 weeks before the screening visit
- Presence of any addiction, alcohol abuse or specific disease that would not allow the patient to understand the essence and requirements and potential consequences of the participation to the clinical trial
- Signs suggestive of the patient being unable to follow the visit schedule as required (for example for professional obligations)
- Treatment with cyclosporine, or tacrolimus, 3 month or less before screening
- Oral Treatment with antibiotics 3 weeks or less before screening
- Topical treatment with steroid- or mesalazine-containing applications 3 weeks or less before screening
- Treatment with bile acid bile acid binding agent (e.g. Cholestayramine)6 weeks or less before screening
- Infectious diseases (HIV, hep B, hep C, tuberculosis, listeriosis, positive clostridium-difficile-toxin- proof in faeces)
- Current presence of intra-abdominal abscess or Fistula
- Cholestatic liver disease, bowel or biliary obstruction
- Dysphagia or swallowing disorders
- Known malignancy or history of malignancy
- Having undergone intestinal surgery within 6 months from screening
- Status after intestinal surgery with more then 100cm of resected bowel.
- Short bowel syndrome
- Planned -gastrostomy, ileostomy or colostomy.
- Pregnancy and lactation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01203254
|Hochschulambulanz Med. Klinik I - Charite-
|Berlin, Germany, 12200 |
|Praxis Dr. Mroß
|Berlin, Germany, 10318 |
|Hamburgisches Forschungsinstitut für CED
|Hamburg, Germany, 20148 |
|Universitätsklinikum des Saarlandes -Innere Medizin-
|Homburg, Germany, 66424 |
|Leipzig, Germany, 04105 |
|CED - Zentrum der Universität München - Klinikum Grosshadern
|Munich, Germany, 81377 |
||Florian Beigel, M.D.
||Klinikum der Universität München - Grosshadern
No publications provided by Klinikum der Universitaet Muenchen, Grosshadern
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Beigel F, Teich N, Howaldt S, Lammert F, Maul J, Breiteneicher S, Rust C, Göke B, Brand S, Ochsenkühn T. Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: a randomized, double-blind, placebo-controlled study. J Crohns Colitis. 2014 Nov 1;8(11):1471-9. doi: 10.1016/j.crohns.2014.05.009. Epub 2014 Jun 19.
||Florian Beigel, Dr. med., Klinikum der Universitaet Muenchen, Grosshadern
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 15, 2010
||April 17, 2013
||Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Keywords provided by Klinikum der Universitaet Muenchen, Grosshadern:
Bile Acid Malabsorption
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Digestive System Diseases
Inflammatory Bowel Diseases
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action