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

NCT01203254 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-04-18

No results posted yet for this study

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.

Conditions

  • Crohns Disease
  • Bile Acid Malabsorption

Interventions

DRUG

Colesevelam

Colesevelam 625 mg tablet; 3 times daily 2 tablets

DRUG

Placebo

Placebo tablet: 3 times daily 2 tablets

Sponsors & Collaborators

  • Florian Beigel

    lead OTHER

Principal Investigators

  • Florian Beigel, M.D. · Klinikum der Universität München - Grosshadern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01203254 on ClinicalTrials.gov