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NCT01331213 · ClinicalTrials.gov registry record · Phase 4
Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome
A Phase 4 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 4
- Development phase
- 18
- Enrollment target
NCT01331213: Completed Phase 4 study, sponsored by Mayo Clinic.
NCT01331213 is a Phase 4 study that has completed, run by Mayo Clinic. The registered enrollment target is 18 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01331213, a Phase 4 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 18 participants
- Enrollment target
Study Summary
The general aim of the current study is to describe the effect of pregabalin on colonic and sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C). Study hypotheses: 1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation ratings in response to balloon distension in the colon relative to pre-pregabalin treatment. 2. Single-dose pregabalin 200 mg will increase colonic compliance and decrease colonic pain and gas thresholds in patients with irritable bowel syndrome constipation predominant. 3. Single-dose pregabalin 200mg increases the colonic phasic and tonic response to a standardized meal.
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 balloon catheter was inserted in the mid-descending or junction of the sigmoid and descending colon, the balloon was inflated. After an initial conditioning distension to 20 mm Hg, colonic compliance was measured by step-wise inflation with increments of 4 mm Hg. Colonic compliance was analyzed by a validated linear interpolation met
Interventions
- DRUG Placebo
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2011-04 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT01331213 record still lists
NCT01331213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01331213 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01331213 about?
NCT01331213 is a clinical study titled "Pregabalin on Colonic Motor and Sensory Function in Constipation Predominant Irritable Bowel Syndrome". The general aim of the current study is to describe the effect of pregabalin on colonic and sensory functions in adults with constipation predominant irritable bowel syndrome (IBS-C). Study hypotheses: 1. Single-dose pregabalin 200mg increases sensation thresholds and decreases sensation ratings i...
What is the current status of trial NCT01331213?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 18 participants. The study started on 2011-04. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01331213?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT01331213?
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 NCT01331213's enrollment target sits among peer trials
18 1842nd of 2000 higher than 147 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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