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NCT01096290 · ClinicalTrials.gov registry record · Phase 4

Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

A Phase 4 study, sponsored by University of South Alabama.

Terminated
Registry status
Phase 4
Development phase
23
Enrollment target

NCT01096290: Clinical Trial Phase 4 study, sponsored by University of South Alabama.

NCT01096290 is a Phase 4 study that was terminated before completion, run by University of South Alabama. The registered enrollment target is 23 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01096290, a Phase 4 study, was terminated before completion, sponsored by University of South Alabama.

TERMINATED
Registry status
Phase 4
Development phase
23 participants
Enrollment target

Study Summary

Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.

Primary Outcome

Subjects will report symptoms by questionnaire

Interventions

  • DRUG Matched placebo
  • DRUG lubiprostone

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2010-04
Est. Completion 2012-09
Phase Phase 4
University of South Alabama

17 total trials

Why NCT01096290 stopped before completion

NCT01096290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).

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

NCT01096290 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01096290 about?

NCT01096290 is a clinical study titled "Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications". Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outc...

What is the current status of trial NCT01096290?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 23 participants. The study started on 2010-04. Estimated completion is 2012-09.

What interventions are being tested in trial NCT01096290?

The interventions under investigation include: Matched placebo (DRUG), lubiprostone (DRUG).

Who is sponsoring clinical trial NCT01096290?

This trial is sponsored by University of South Alabama, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01096290's enrollment target sits among peer trials

23 1725th of 2000 higher than 270 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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Source: ClinicalTrials.gov NCT01096290, the US trial registry maintained by the National Library of Medicine. NCT01096290 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.