CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 200mgfrom 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/NCT01331213
NCT01331213Phase 4Completed
CompareCT.gov

Effect of Pregabalin on Colonic Motor and Sensory Function in Adults With Irritable Bowel Syndrome With Predominant Constipation

Mayo Clinic·interventional·Posted Apr 7, 2011·Updated Mar 3, 2014

In Brief

A Phase 4 clinical trial evaluating Pregabalin and Placebo for Irritable Bowel Syndrome. Completed, enrolled 18 participants across 1 site.

Detailed Summary

The general aim of the current study is to describe the effect of pregabalin on colonic and sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C). Study hypotheses: 1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation ratings in response to balloon distension in the colon relative to pre-pregabalin treatment. 2. Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic pain and gas thresholds in patients with irritable bowel syndrome constipation predominant. 3. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a standardized meal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIrritable Bowel Syndrome
CountriesUnited States
CollaboratorsNational Center for Research Resources (NCRR)

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2011
Enrollment StartApr 1, 2011
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 15.2 years ago

Interventions

Pregabalindrug

FDA approved medication (capsules) at 200mg dose.

Placebodrug

Placebo capsules