Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Center for Research Resources (NCRR)
• Treatments: Pregabalin

Criteria

Inclusion criteria:

• Male or females with Constipation Predominant IBS, age 18-65

Exclusion criteria:

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

• Uncontrolled hypertension

• Use of medications that may interact with the study medication

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

• Pregnancy

• History of chronic renal insufficiency (serum creatinine >1.5mg/dL)

• Psychiatric or psychologic dysfunction

• Current pelvic floor dysfunction

• diagnosis of lactose intolerance