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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Placebo
  • DRUG Pregabalin

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2011-04
Est. Completion 2013-02
Phase Phase 4

Sponsor

Mayo Clinic

2,844 total trials

What the Registry Record Tells You About NCT01331213

The ClinicalTrials.gov registry entry for NCT01331213 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01331213 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.