NCT01096290

Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: University of South Alabama · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.

Detailed description

Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation and recently, constipation-predominant irritable bowel syndrome. The Physicians Desk Reference lists over 90 Brand medications with reported incidence associated with constipation over 3%. Little data are available about treatment responses. A recent publication by our group reported treatment success for medication constipation using polyethylene glycol. Since ongoing studies are addressing the role of lubiprostone in opioid constipation, this work will be enrolling medication constipation study subjects not using opioids. In this study, patients who meet diagnostic criteria for constipation will be randomized to receive 28 days of treatment with lubiprostone 24mcg twice a day. Data will be collected to evaluate therapeutic outcome.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	lubiprostone	24mcg BID, capsule, oral 30days
DRUG	Matched placebo	Twice daily for 30days, oral

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2010-03-31
• Last updated: 2020-11-20
• Results posted: 2020-09-09

Locations

1 site across 1 country: United States