Status:
COMPLETED
Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
Lead Sponsor:
Texas Tech University Health Sciences Center, El Paso
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to determine if lubiprostone may change the rate of movement of food and activities in the stomach and intestines in subjects whose gastrointestinal (GI) tract is slower d...
Detailed Description
Lubiprostone is an effective treatment for chronic constipation. The mechanism of action of lubiprostone is through increasing fluid and mucus secretion and improving lubrication of the intestinal lum...
Eligibility Criteria
Inclusion
- 18-65 years old
- At least a 6 months history of constipation. Constipation defined as follows:
- Less than three complete spontaneous bowel movements per week and one or more of the following:
- At least 25% of stools are very hard and/or hard stools
- Sensation of incomplete evacuation following at least 25% of bowel movements.
- Straining on at least 25% of defecations. The above criteria are only applicable to spontaneous bowel movements. Patients who have no spontaneous bowel movements (bowel movements are preceded by laxative intake) are considered constipated and are eligible for this study.
- For patients ≥ 50 years of age, normal colonic anatomy as documented by colonoscopy, double-contrast barium enema, or flexible sigmoidoscopy performed within the previous 5 years.
Exclusion
- Pregnancy or lactation.
- Subjects unwilling to practice adequate contraception throughout the period of screening through 14 days after the study termination.
- Use of laxatives 3 days immediately prior to randomization (except fiber or bulking agents).
- Use of any of the following drugs within 3 days prior to randomization:
- Prokinetic agents (tegaserod, domperidone, cisapride, metoclopramide, erythromycin).
- Medication containing opiates.
- Anti-spasmodic (e.g., atropine, hyoscyamine, scopolamine, glycopyrrolate).
- Use of illegal drugs
- Regular consumption of 2 drinks of alcohol per day.
- Chronic nonsteroidal antiinflammatory drugs (NSAIDs) use
- Chronic use of H2 receptor antagonist or proton pump inhibitors (PPIs) within 14 days prior to screening.
- History of gastric or duodenal ulcer, inflammatory bowel disease(IBD), or chronic non-ulcer dyspepsia.
- Diabetes Mellitus (DM) type 1, Parkinson's disease.
- Existence of any medical condition that requires chronic therapy.
- Positive H. pylori serology
- Chronic active diverticulosis
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01469819
Start Date
June 1 2012
End Date
February 1 2015
Last Update
June 9 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Texas Tech University Health Sciences Center
El Paso, Texas, United States, 79905