The Effectiveness of Lubiprostone in Constipated Diabetics
Public ClinicalTrials.gov record NCT01170039. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double Blind, Placebo-controlled Trial to Examine the Effectiveness of Lubiprostone on Constipation Symptoms and Colon Transit Time in Diabetic Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01170039
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 121 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 30 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 31, 2010
- Primary completion
- Sep 30, 2014
- Completion
- Sep 30, 2014
- Last update posted
- Mar 14, 2016
2010 – 2014
United States locations
- U.S. sites
- 2
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Atlanta Veterans Administration Hospital | Atlanta | Georgia | 30033 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01170039, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 14, 2016 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01170039 live on ClinicalTrials.gov.