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NCT01166789 · ClinicalTrials.gov registry record · Phase 1

Lubiprostone Effects on Visceral Pain Sensitivity

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
62
Enrollment target

NCT01166789: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT01166789 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 62 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01166789, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
62 participants
Enrollment target

Study Summary

The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water and sodium. The increased fluid causes food residue to move through the bowel more quickly and makes the stools softer. First, we want to test the idea that Lubiprostone works by making a person less sensitive to pain. Second, we want to confirm that Lubiprostone decreases the time it takes fecal matter to travel through your GI tract, referred to as transit time.

Interventions

  • DRUG Placebo
  • DRUG Lubiprostone

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2008-02
Est. Completion 2010-08
Phase Phase 1

What the finished NCT01166789 record still lists

NCT01166789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.

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

NCT01166789 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01166789 about?

NCT01166789 is a clinical study titled "Lubiprostone Effects on Visceral Pain Sensitivity". The purpose of this research study is to determine how Lubiprostone, a medication used to treat irritable bowel syndrome with constipation predominant symptoms (IBS-C), works to reduce clinical pain. Lubiprostone acts in the small intestine to cause an increase in the secretion of chloride, water an...

What is the current status of trial NCT01166789?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2008-02. Estimated completion is 2010-08.

What interventions are being tested in trial NCT01166789?

The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).

Who is sponsoring clinical trial NCT01166789?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01166789's enrollment target sits among peer trials

62 824th of 2000 higher than 1,173 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01166789, the US trial registry maintained by the National Library of Medicine. NCT01166789 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.