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

Crohns Disease Clinical Trial

— COBAM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01203254
• Other study ID #: 2009-010727-91
• Status: Terminated
• Phase: Phase 4
• First received: September 15, 2010
• Last updated: April 17, 2013
• Start date: October 2010
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Klinikum der Universitaet Muenchen, Grosshadern
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 7a-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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Acid Malabsorption
• Crohn Disease
• Crohns Disease
• Malabsorption Syndromes

Intervention

Drug:
• Colesevelam
Colesevelam 625 mg tablet; 3 times daily 2 tablets
• Placebo
Placebo tablet: 3 times daily 2 tablets

Locations

Country	Name	City	State
Germany	Hochschulambulanz Med. Klinik I - Charite-	Berlin
Germany	Praxis Dr. Mroß	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

Sponsors (1)

Lead Sponsor	Collaborator
Florian Beigel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of fluid stool > 30 %		4 weeks after baseline	No
Secondary	Improvement of Stool Consistency	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	No
Secondary	Improvement of Quality of Life.	Proportion of patients on cholestagel compared to placebo that reaches an improvement of the Quality of Life.	4 weeks after baseline	No
Secondary	Change of median liquid or soft stool frequency/per day.		4 weeks after baseline	No