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

April 17, 2013 updated by: Florian Beigel
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10318
        • Praxis Dr. Mroß
      • Berlin, Germany, 12200
        • Hochschulambulanz Med. Klinik I - Charite-
      • Hamburg, Germany, 20148
        • Hamburgisches Forschungsinstitut für CED
      • Homburg, Germany, 66424
        • Universitätsklinikum des Saarlandes -Innere Medizin-
      • Leipzig, Germany, 04105
        • Internistische Gemeinschaftspraxis
      • Munich, Germany, 81377
        • CED - Zentrum der Universität München - Klinikum Grosshadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Signed informed consent after adequate explanation of the patient information.
  • Male and female patients with CD and 18 to 65 years of age in clinical remission with a Crohns Disease Activity Index (CDAI) score of 150 or less, with symptoms of functional BAM or symptoms of BAM after small bowel resection with a frequency of at least 3 to maximal 15 liquid or soft stools per day.

  • Stable medical treatment of CD for a minimal period of 3 months preceding the screening visit, consisting of

    • either continuous oral treatment of aminosalicylate, prednisolone (a maximum 10 mg/day), azathioprine, 6-mercaptopurine, or methotrexate
    • or supporting periodic treatment* with TNF-alpha AK (Infliximab, Adalimumab, Certolizumab) (for patients on TNF-alpha, dosing with TNF-alpha should coincide with baseline visit)
  • Blood serum CRP value of less or equal then 1 mg/dl (10 mg/l).
  • BAM assessed with a blood test on a 7α-hydroxy-4-cholesten-3-on excretion of equal or more than 50 ng/ml

Exclusion criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo tablet: 3 times daily 2 tablets
Active Comparator: Cholestagel
Drug: Colesevelam
Colesevelam 625 mg tablet; 3 times daily 2 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of fluid stool > 30 %
Time Frame: 4 weeks after baseline
4 weeks after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Stool Consistency
Time Frame: 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.
4 weeks after baseline
Improvement of Quality of Life.
Time Frame: 4 weeks after baseline
Proportion of patients on cholestagel compared to placebo that reaches an improvement of the Quality of Life.
4 weeks after baseline
Change of median liquid or soft stool frequency/per day.
Time Frame: 4 weeks after baseline
4 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florian Beigel

Investigators

  • Principal Investigator: Florian Beigel, M.D., Klinikum der Universität München - Großhadern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

September 15, 2010

First Submitted That Met QC Criteria

September 15, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

April 18, 2013

Last Update Submitted That Met QC Criteria

April 17, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-010727-91

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohns Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Albania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe