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NCT01170039 · ClinicalTrials.gov registry record · Phase 4
The Effectiveness of Lubiprostone in Constipated Diabetics
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 121
- Enrollment target
NCT01170039 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 121 participants.
The verdict
NCT01170039, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 121 participants
- Enrollment target
Study Summary
The investigators will recruit a total of 136 diabetic men and women with constipation into this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours after initiation of study drug (SBMs) in all patients two weeks before treatment with lubiprostone as well as measure baseline colonic transit using the Smartpill pH capsule. Colon transit reflects that rate of colonic peristalsis and movement of stool through the large bowel. Patients will receive either lubiprostone 24 micrograms (mcg) orally twice a day for 8 weeks or placebo. Primary and secondary endpoints will be the number of SBMs/week and colonic transit time as measured by the Smartpill capsule, respectively. The number of SBMs/week will be evaluated at 0, 2, 4 and 8 weeks after initiation of therapy. The investigators will over-sample African American patients to achieve approximately 50% enrollment of this group. In a subanalysis, the investigators will assess response to treatment between the general population and African Americans. We hypothesize that lubiprostone will significantly increase the number of SBMs as well as decrease colonic transit time and improve quality of life in constipated diabetic patients compared with placebo.
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 121 participants |
| Start Date | 2010-09 |
| Est. Completion | 2014-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01170039
The ClinicalTrials.gov registry entry for NCT01170039 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 121 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01170039 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01170039 about?
NCT01170039 is a clinical study titled "The Effectiveness of Lubiprostone in Constipated Diabetics". The investigators will recruit a total of 136 diabetic men and women with constipation into this study from both The Emory Clinic and The Atlanta Veteran's Administration Hospital. The investigators will track spontaneous bowel movements defined as a bowel movement in 24 hours after initiation of st...
What is the current status of trial NCT01170039?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 121 participants. The study started on 2010-09. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01170039?
The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT01170039?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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