Phase 3
N=37
Lubiprostone Effect on Gastrointestinal Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
Chronic Idiopathic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01469819 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Aug 2016
Primary outcome: Primary: Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. — 7.0; 5.9; 56.7; 64.2 Hours — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Texas Tech University Health Sciences Center, El Paso
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Reduction (Hours and Minutes) of Gastric Emptying (GE), Small Bowel (SB), Large Bowel (LB) and Whole Gut (WG) Transits Measured by SmartPill in Chronically Constipated Patients Before and After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day. |
7.0; 5.9; 56.7; 64.2; 9.3; 4.5 | <0.01 sig |
| SECONDARY Changes in Number of Bowel Movements in Chronically Constipated Patients After 2 Weeks of Therapy With Lubiprostone 24mcg Twice a Day (BID). |
1.9; 4.6 | <0.01 sig |
| SECONDARY Changes in Time of GE, SB, LB and WG Transits Measured by SmartPill After 2 Weeks of Lubiprostone 24mcg BID in Chronically Constipated Patients. |
9.6; 3.9; 7.2; 4.5; 45.9; 70.1 | <0.01 sig |
| SECONDARY Changes in Number of Bowel Movements Per Week Changes GE, SB, LB and WG Transit Times Measured by SmartPill in Chronically Constipated Patients Treated for 2 Weeks With Lubiprostone 24mcg Twice a Day. |
1.8; 2.1; 6.0; 3.0 | <0.01 sig |
| SECONDARY Elimination of Small Intestine Bacterial Overgrowth (SIBO) in Chronically Constipated Patients Treated With Lubiprostone 24mcg Twice a Day for 2 Weeks. |
17; 10; 7 | — |
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 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.
Eligibility Criteria
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:
- 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 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
Data sourced from ClinicalTrials.gov (NCT01469819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.