Pregabalin and Colonic Function

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: National Center for Research Resources (NCRR); National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Pregabalin

Criteria

Inclusion criteria:

• Healthy males or females

Exclusion criteria:

• Abdominal surgery other than appendectomy, laparoscopic cholecystectomy, cesarean section, vaginal or laparoscopic hysterectomy or tubal ligation

• A history of chronic gastrointestinal or systemic illnesses that could affect gastrointestinal motility

• Any history of hypertension

• Use of medications that may alter gastrointestinal motility or interact with the study medications

• Use of any of the study medications within the past 30 days

• Pregnancy

• Chronic renal insufficiency (serum creatinine >1.5 mg/dL)

• Psychiatric or psychologic dysfunction.