- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096290
Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Alabama
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Mobile, Alabama, United States, 36693
- USA Pavilion at Infirmary West
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult male or female outpatient age 19 or older.
Patients meet International Congress of Gastroenterology (ROME III) clinical criteria for constipation*:
Must include two or more of the following:
- Straining in > 1/4 defecations;
- Lumpy or hard stools > 1/4 defecations;
- Sensation of incomplete evacuation in 1/4 defecations;
- Sensation of anorectal obstruction/blockage in > 1/4 defecations;
- <3 defecations/week.
- Loose stools are rarely present without the use of laxatives.
- There are insufficient criteria for irritable bowel syndrome. *Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
- Use of one or more of listed medications known to cause constipation.
- If female and of childbearing potential, patient must be surgically sterilized or using oral contraceptives, depot contraceptives, intrauterine device, or testifies that she is monogamous with a vasectomized partner, or practices abstinence and will continue to do so during the duration of study. Mandatory compliance is required. Serum pregnancy tests will be performed at screening and during needed follow-up. Negative results will be received before inclusion and administration of first study dose. If pregnancy occurs during the trial, the investigator is notified immediately resulting in prompt discontinuation.
- Study subjects must not have received lubiprostone for more than 72 hours.
- Written informed consent.
Exclusion Criteria:
- Known or suspected obstruction, gastric retention, ileus, perforation, fecal impaction or inflammatory bowel disease.
- Severe diarrhea.
- Prior small bowel or colonic resection or colostomy.
- Weight < 80 lbs.
- If the patient has constipation that according to the investigator's clinical judgment is not the result of constipating medications but is suffering from a secondary cause including but limited to factors that are dietary, neurologic, congenital, diabetic or hypothyroid.
- Positive stool hemoccult (Can be included if colonoscopic evaluation is subsequently negative).
- Significant cardiac, renal or hepatic insufficiency.
- Pregnant or expecting to become pregnant within 120 days of study enrollment.
- Lactating or breast feeding.
- Subjects using opioid medications.
- Subjects who in the opinion of the investigator would be unable to comply adequately with the study plan.
- Use of investigational drugs in the last 30 days.
- Patients with known allergy to lubiprostone.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lubiprostone 24mcg BID for 30 days
Active medication
|
24mcg BID, capsule, oral 30days
Other Names:
|
Placebo Comparator: Placebo
Placebo, matched, blinded
|
Twice daily for 30days, oral
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Relief of Constipation Defined by Modified ROME Criteria
Time Frame: 30 days
|
Subjects will report symptoms by questionnaire
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency
Time Frame: 30 days
|
Subjects will report stool frequency by questionnaire
|
30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jack A DiPalma, M.D., University of South Alabama College of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-250
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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