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NCT01094808 · ClinicalTrials.gov registry record · Phase 4
Pregabalin and Colonic Function
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT01094808: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT01094808 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 62 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
NCT01094808, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals. The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensation ratings, and increases compliance in response to balloon distension in the colon; 2) pregabalin reduces colonic phasic and tonic motility in response to a standardized meal; and 3) sensation ratings are lower with higher colonic compliance.
Primary Outcome
The sensory threshold for first perception of pain was measured by stepwise inflation of the balloon in increments of 4 mm Hg at 60 second intervals. The balloon was placed in the mid-descending or junction of the sigmoid and descending colon. During this assessment participants were asked to report when they had the first perception of pain. The investigator recorded the threshold pressure at which the participants reported this sensation.
Interventions
- DRUG Placebo
- DRUG Pregabalin
- OTHER Bowel preparation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-02 |
| Phase | Phase 4 |
What the finished NCT01094808 record still lists
NCT01094808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 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.
NCT01094808 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01094808 about?
NCT01094808 is a clinical study titled "Pregabalin and Colonic Function". This study is being done to evaluate the effects of pregabalin, a drug approved for anticonvulsive therapy and for neuropathic pain, on colonic and sensory functions in healthy individuals. The specific study hypotheses were as follows: 1) pregabalin increases sensation thresholds, decreases sensat...
What is the current status of trial NCT01094808?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2010-03. Estimated completion is 2011-02.
What interventions are being tested in trial NCT01094808?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG), Bowel preparation (OTHER).
Who is sponsoring clinical trial NCT01094808?
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 NCT01094808's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 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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