Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
| Status: | Completed |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | June 2012 |
| End Date: | February 2015 |
The Effect of Lubiprostone on Transit Times Within the Alimentary Tract, Measured by Novel Smartpill Methodology in Patients With Chronic Constipation
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 due to constipation.
To be able to measure the time difference in the duration of transit of the FDA approved
SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure
to lubiprostone.
The investigators anticipate to capture the possibility to reduce/eliminate the small
intestinal bacterial overgrowth in chronically constipated patients after administration of
study drug- lubiprostone.
food and activities in the stomach and intestines in subjects whose gastrointestinal (GI)
tract is slower due to constipation.
To be able to measure the time difference in the duration of transit of the FDA approved
SmartPill capsule in all segments of gastrointestinal (GI) tract before and after exposure
to lubiprostone.
The investigators anticipate to capture the possibility to reduce/eliminate the small
intestinal bacterial overgrowth in chronically constipated patients after administration of
study drug- lubiprostone.
Inclusion Criteria:
- 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:
1. At least 25% of stools are very hard and/or hard stools
2. Sensation of incomplete evacuation following at least 25% of bowel
movements.
3. 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 Criteria:
- 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
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