Crohns DiseasePhase 4COBAMNCT01203254
Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
A Phase 4 study testing Colesevelam in people with Crohns Disease and Bile Acid Malabsorption, run by Florian Beigel at 6 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohns Disease, Bile Acid Malabsorption
- What is being tested?
- Colesevelam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 6 sitesGermany
- Study dates
- Oct 2010to Mar 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Praxis Dr. Mroß
Berlin, 10318
Hochschulambulanz Med. Klinik I - Charite-
Berlin, 12200
Hamburgisches Forschungsinstitut für CED
Hamburg, 20148
Universitätsklinikum des Saarlandes -Innere Medizin-
Homburg, 66424
Internistische Gemeinschaftspraxis
Leipzig, 04105
CED - Zentrum der Universität München - Klinikum Grosshadern
Munich, 81377
About this study
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
- Being tested
- Colesevelam, Placebo
- Keywords
- Colesevelam, IBD, Bile Acid Malabsorption, Crohns disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColesevelamDrug
Colesevelam 625 mg tablet; 3 times daily 2 tablets
PlaceboDrug
Placebo tablet: 3 times daily 2 tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Cholestagel | Active comparator | Not described Receives: Drug: Colesevelam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of fluid stool > 30 %
Measured: 4 weeks after baseline
Secondary outcomes (3)
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.
Measured: 4 weeks after baseline
Improvement of Quality of Life.
Proportion of patients on cholestagel compared to placebo that reaches an improvement of the Quality of Life.
Measured: 4 weeks after baseline
Change of median liquid or soft stool frequency/per day.
Measured: 4 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florian Beigel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Florian Beigel, Klinikum der Universitaet Muenchen, Grosshadern
- Investigators
- Florian Beigel, M.D., Principal investigator, Klinikum der Universität München - Grosshadern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203254
- Sponsor's protocol ID
- 2009-010727-91
- Other IDs
- 2009
- Acronym
- COBAM
- Status last verified
- Apr 2013
- First submitted
- 15 Sep 2010
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24953836
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colesevelam for the Treatment of Bile Acid Malabsorption in Patients With Crohn's Disease
- ClinicalTrials.gov ID
- NCT01203254
- Acronym / sponsor ID
- COBAM / 2009-010727-91
- Conditions
- Crohns Disease, Bile Acid Malabsorption
- Keywords
- Colesevelam, IBD, Bile Acid Malabsorption, Crohns disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient enrollment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Florian BeigelUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Cholestagel | Active comparator | Drug: Colesevelam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColesevelamColesevelam 625 mg tablet; 3 times daily 2 tablets | Drug | Cholestagel |
| PlaceboPlacebo tablet: 3 times daily 2 tablets | Drug | Placebo |
Primary outcome
Reduction of fluid stool > 30 %
Time frame: 4 weeks after baseline
3 secondary outcomes
Improvement of Stool Consistency
Time frame: 4 weeks after baseline
Improvement of Quality of Life.
Time frame: 4 weeks after baseline
Change of median liquid or soft stool frequency/per day.
Time frame: 4 weeks after baseline
Results and safety
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
- Derived from this study: PubMed 24953836Beigel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Beigel, M.D. principal investigator
Klinikum der Universität München - Grosshadern
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colesevelam in people with Crohns Disease and Bile Acid Malabsorption, run by Florian Beigel at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of fluid stool > 30 % (time frame: 4 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01203254, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013.