Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications|
- Relief of constipation defined by modified ROME criteria [ Time Frame: 30 days ] [ Designated as safety issue: No ]Subjects will report symptoms by questionnaire
- Frequency [ Time Frame: 30 days ] [ Designated as safety issue: No ]Subjects will report stool frequency by questionnaire
|Study Start Date:||April 2010|
|Study Completion Date:||September 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Lubiprostone 24mcg BID for 30 days
24mcg BID, capsule, oral 30days
Other Name: Amitiza
Placebo Comparator: Placebo
Placebo, matched, blinded
Drug: Matched placebo
Twice daily for 30days, oral
Other Name: Placebo, sugar pill
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096290
|United States, Alabama|
|USA Pavilion at Infirmary West|
|Mobile, Alabama, United States, 36693|
|Principal Investigator:||Jack A DiPalma, M.D.||University of South Alabama College of Medicine|