CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Colesevelam +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00911612
NCT00911612Phase 2Completed
CompareCT.gov

A Phase IIB Study to Evaluate the Effects of Welchol (Colesevelam Hydrochloride) on Colonic Transit, Intestinal Permeability and Bowel Function in Diarrhea-predominant Irritable Bowel Syndrome (D-IBS)

Mayo Clinic·interventional·Posted Jun 2, 2009·Updated Apr 4, 2012

In Brief

A Phase 2 clinical trial evaluating Colesevelam and Placebo for Irritable Bowel Syndrome and Diarrhea. Completed, enrolled 24 participants across 1 site.

Detailed Summary

Our hypothesis is that the medication approved for treatment of high blood cholesterol levels, Colesevelam HCl (WELCHOL), decreases colonic transit and permeability in patients with diarrhea due to irritable bowel syndrome. This effect is thought to result from the effect of the medication on bile acids, which can cause diarrhea.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome, Diarrhea
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2, 2009
Enrollment StartJan 1, 2009
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 17.1 years ago

Interventions

Colesevelamdrug

Welchol (Colesevelam HCL) 1.875 gram twice daily for 12-14 days

Placebodrug

Inert capsule matching the study drug, given twice daily