Bile acid diarrhoea MedDRA version: 20.1 Level: PT Classification code 10069703 Term: Bile acid malabsorption System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 20.1 Level: LLT Classification code 10066557 Term: Chronic diarrhoea System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Cholestagel
Product Name: Cholestagel
Pharmaceutical Form: Tablet
INN or Proposed INN: Cholestagel
CAS Number: 182815-44-7
Other descriptive name: COLESEVELAM HYDROCHLORIDE
Concentration u
Sponsors
Zealand University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with suspected bile acid diarrhoea referred for SeHCAT retention test at Holbæk, Hvidovre, Aarhus, or Aalborg university hospitals • age >= 18yo. and =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: • Inflammatory bowel disease, including microscopic colitis • Investigator assessed debilitating chronic disease (WHO performance score 3-5) • Prior treatment with colesevelam • Treatment with laxatives or constipants during the study o Except for stable dose the last four weeks of psyllium husk and opioids for pain • Pregnancy • Breastfeeding women • Crucial medication that cannot be separated appropriately from colesevelam o i.e. taken one hour before or 4 hours after colesevelam. • Oral anticoagulation, both warfarin, and new oral anticoagulation • Treatment with cyclosporine within two months • Bowel obstruction (subileus or ileus) • Biliary obstruction • Short Bowel Syndrome • Bowel ostomy • Allergy to colesevelam or its constituents • Allergy to placebo constituents (excluding lactose) • Investigator assessed high risk of non-compliance • If on statin/fibrate medication, unwilling to pause medication between study visits 1 and 2 • Acute suspected or proven viral gastroenteritis within the recent 4 weeks • Acute non-viral gastroenteritis within the recent 8 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the efficacy and safety of treating bile acid diarrhoea with colesevelam. ;Secondary Objective: To correlate both the current scintigraphic SeHCAT test and the biochemical markers of BAD fibroblast growth factor 19 (FGF19) and 7a-hydroxy-4-cholesten-3-one (C4) with colesevelam treatment response. this will establish clinical meaningful cut-offs and improve treatment of bile acid diarrhoea;Primary end point(s): Placebo-controlled intention to treat (ITT) diarrhoea remission rate defined by the Hjortswang criteria for colesevelam in patients with BAD defined by C4 > 46 ng/mL;Timepoint(s) of evaluation of this end point: Baseline six days compared with the last seven of total 12 treatment days. Analysis of biobank blood samples after Last Subject Last Visit. This is expected aprox. primo 2022. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Per protocol (PP) analysis for the primary endpoint 2. Placebo-controlled diarrhoea ITT remission rate for colesevelam defined by the Hjortswang criteria in patients with BAD defined by SeHCAT = 10% 3. Placebo-controlled diarrhoea PP remission rate for colesevelam defined by the Hjortswang criteria in patients with BAD defined by SeHCAT = 10% 4. Placebo-controlled effect of colesevelam in patients with bile acid diarrhoea defined with C4 a. on the absolute number of stools (mean per day over 6 or 7 days) b. on the total number of Bristol 6 and 7 stools (mean per day over 6 or 7 days) Change in health-related quality of life assesses as the change in the total score of the Short Health Scale before vs. after;Timepoint(s) of evaluation of this end point: As for the primary endpoint | — |
Countries
Denmark
Contacts
Public ContactDepartment of Medicine
Zealand University Hosipital
Outcome results
None listed