Pregabalin and Colonic Function

Completed · Phase 4 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01094808

Run by

Mayo Clinic

People needed

62

Starts

2010-03-01

Expected to finish

2011-02-01

Last updated by the study team

2012-03-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy males or females

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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