At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Pregabalin on Colonic Sensorimotor Function in Healthy Adults.
In Brief
A Phase 4 clinical trial evaluating Pregabalin, Placebo, and 1 other intervention for Healthy. Completed, enrolled 62 participants across 1 site.
Detailed Summary
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals. The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and increases compliance in response to balloon distension in the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
Study Details
Timeline
Interventions
FDA approved medication (capsules) at 75 mg and 200 mg doses
Placebo capsules
Polyethylene glycol electrolyte solution bowel preparation