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

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

Sponsors

Lead Sponsor: Florian Beigel

Source Klinikum der Universitaet Muenchen, Grosshadern
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.

Overall Status Terminated
Start Date October 2010
Completion Date March 2013
Primary Completion Date March 2013
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction of fluid stool > 30 % 4 weeks after baseline
Secondary Outcome
Measure Time Frame
Improvement of Stool Consistency 4 weeks after baseline
Improvement of Quality of Life. 4 weeks after baseline
Change of median liquid or soft stool frequency/per day. 4 weeks after baseline
Enrollment 34
Condition
Intervention

Intervention Type: Drug

Intervention Name: Colesevelam

Description: Colesevelam 625 mg tablet; 3 times daily 2 tablets

Arm Group Label: Cholestagel

Intervention Type: Drug

Intervention Name: Placebo

Description: Placebo tablet: 3 times daily 2 tablets

Arm Group Label: Placebo

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Florian Beigel, M.D. Principal Investigator Klinikum der Universität München - Grosshadern
Location
Facility:
Praxis Dr. Mroß | Berlin, 10318, Germany
Hochschulambulanz Med. Klinik I - Charite- | Berlin, 12200, Germany
Hamburgisches Forschungsinstitut für CED | Hamburg, 20148, Germany
Universitätsklinikum des Saarlandes -Innere Medizin- | Homburg, 66424, Germany
Internistische Gemeinschaftspraxis | Leipzig, 04105, Germany
CED - Zentrum der Universität München - Klinikum Grosshadern | Munich, 81377, Germany
Location Countries

Germany

Verification Date

April 2013

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: Klinikum der Universitaet Muenchen, Grosshadern

Investigator Full Name: Florian Beigel

Investigator Title: Dr. med.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Placebo

Type: Placebo Comparator

Label: Cholestagel

Type: Active Comparator

Acronym COBAM
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov