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NCT00953043 · ClinicalTrials.gov registry record · Phase 4
Lubiprostone, Colonic Motility and Sensation
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00953043: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT00953043 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00953043, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.
Primary Outcome
Colonic compliance is a measure of the "stiffness" of the colon, that is, what pressure was needed to reach half the maximum volume of the colon. After the barostat catheter was inserted in the colon, the catheter was connected to a barostat machine. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg up to 64 mm Hg. Colonic compliance was analyzed by a validated linear interpolation method. The pressure at half
Interventions
- DRUG Placebo
- DRUG lubiprostone
- OTHER Bowel preparation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-09 |
| Est. Completion | 2009-07 |
| Phase | Phase 4 |
What the finished NCT00953043 record still lists
NCT00953043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00953043 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00953043 about?
NCT00953043 is a clinical study titled "Lubiprostone, Colonic Motility and Sensation". This study is being done to evaluate the effects of lubiprostone, a drug approved and used for constipation, on pattern of contractions of the colon and the colon's sensitivity to distension.
What is the current status of trial NCT00953043?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2007-09. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00953043?
The interventions under investigation include: Placebo (DRUG), lubiprostone (DRUG), Bowel preparation (OTHER).
Who is sponsoring clinical trial NCT00953043?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00953043's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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