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

NCT01203254 | Terminated Phase 4

• 1 other identifier: 2009-010727-91
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 6

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.

Conditions

Crohns Disease; Bile Acid Malabsorption

Keywords

Colesevelam; IBD; Bile Acid Malabsorption; Crohns disease

Outcome Measures

Primary Outcomes (1)

• Reduction of fluid stool > 30 %

  4 weeks after baseline

Secondary Outcomes (3)

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Cholestagel

ACTIVE COMPARATOR

Drug: Colesevelam

Interventions

Colesevelam DRUG

Colesevelam 625 mg tablet; 3 times daily 2 tablets

Cholestagel

Placebo DRUG

Placebo tablet: 3 times daily 2 tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Florian Beigel: lead

Study Sites (6)

Praxis Dr. Mroß

Berlin, 10318, Germany

Location

Hochschulambulanz Med. Klinik I - Charite-

Berlin, 12200, Germany

Location

Hamburgisches Forschungsinstitut für CED

Hamburg, 20148, Germany

Location

Universitätsklinikum des Saarlandes -Innere Medizin-

Homburg, 66424, Germany

Location

Internistische Gemeinschaftspraxis

Leipzig, 04105, Germany

Location

CED - Zentrum der Universität München - Klinikum Grosshadern

Munich, 81377, Germany

Location

Related Publications (1)

• Beigel F, Teich N, Howaldt S, Lammert F, Maul J, Breiteneicher S, Rust C, Goke B, Brand S, Ochsenkuhn T. Colesevelam for the treatment of bile acid malabsorption-associated diarrhea in patients with Crohn's disease: a randomized, double-blind, placebo-controlled study. J Crohns Colitis. 2014 Nov;8(11):1471-9. doi: 10.1016/j.crohns.2014.05.009. Epub 2014 Jun 19.

  PMID: 24953836 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Colesevelam Hydrochloride

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Allylamine; Amines; Organic Chemicals; Allyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons

Study Officials

• Florian Beigel, M.D.

  Klinikum der Universität München - Grosshadern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. med.

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: October 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 18, 2013

Record last verified: 2013-04

Locations

DE (6)