Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome
Completed · Phase 4 · Has a placebo group
Conditions studied: Irritable Bowel Syndrome
In brief
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.
Key facts
- Study ID
- NCT01331213
- Run by
- Mayo Clinic
- People needed
- 18
- Starts
- 2011-04-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2014-03-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or females with Constipation Predominant IBS, age 18-65
You may not qualify if…
- 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
Where it is running
- Mayo Clinic in Rochester — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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