Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease

Phase 4

Terminated

• Conditions: Crohns Disease; Bile Acid Malabsorption
• Interventions: Drug: Placebo; Drug: Colesevelam

• Registration Number: NCT01203254
• Lead Sponsor: Florian Beigel

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-15
• Study First Submitted QC: 2010-09-15
• Study First Posted: 2010-09-16
• Study Start: 2010-10
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-17
• Last Update Posted: 2013-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Cholestagel	Colesevelam	-

Primary Outcome Measures

Name	Time	Method
Reduction of fluid stool > 30 %	4 weeks after baseline

Secondary Outcome Measures

Name	Time	Method
Improvement of Stool Consistency	4 weeks after baseline	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.	4 weeks after baseline	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.	4 weeks after baseline

Trial Locations

Locations (6)

Praxis Dr. Mroß; 🇩🇪 Berlin, Germany

Hochschulambulanz Med. Klinik I - Charite-; 🇩🇪 Berlin, Germany

Hamburgisches Forschungsinstitut für CED; 🇩🇪 Hamburg, Germany

Universitätsklinikum des Saarlandes -Innere Medizin-; 🇩🇪 Homburg, Germany

Internistische Gemeinschaftspraxis; 🇩🇪 Leipzig, Germany

CED - Zentrum der Universität München - Klinikum Grosshadern; 🇩🇪 Munich, Germany