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NCT00669461 · ClinicalTrials.gov registry record · NA

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

A NA study, sponsored by University of Arkansas.

Terminated
Registry status
NA
Development phase
1
Enrollment target

NCT00669461: Clinical Trial NA study, sponsored by University of Arkansas.

NCT00669461 is a NA study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 1 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00669461, a NA study, was terminated before completion, sponsored by University of Arkansas.

TERMINATED
Registry status
NA
Development phase
1 participants
Enrollment target

Study Summary

Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal cells, it has the potential to improve constipation in patients with PD with no subsequent adverse events on the control of the neurological manifestation of PD. So we hypothesize the following: 1. Lubiprostone will improve ratings on the Bristol stool form scale (BSFS) in patients with PD induced constipation compared to baseline.(primary) 2. Lubiprostone will increase the number of spontaneous bowel movements (SBM) per week, compared to baseline. (secondary) 3. Lubiprostone will improve health related quality of life in subjects with PD induced constipation. ( secondary)

Primary Outcome

The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubipro

Interventions

  • DRUG Lubiprostone

Trial Details

FieldValue
Enrollment Target 1 participants
Start Date 2009-06
Est. Completion 2010-09
Phase NA
University of Arkansas

318 total trials

Why NCT00669461 stopped before completion

NCT00669461 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which Lubiprostone is the first listed.

NCT00669461 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00669461 about?

NCT00669461 is a clinical study titled "Lubiprostone as a Treatment for Constipation in Parkinson's Disease". Delayed colonic transient time secondary to a multi-degenerative process is the most likely cause of constipation in idiopathic PD. Since lubiprostone demonstrated its ability to accelerate colonic transit time in healthy volunteers in addition to activating the chloride channels in the intestinal c...

What is the current status of trial NCT00669461?

This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2009-06. Estimated completion is 2010-09.

What interventions are being tested in trial NCT00669461?

The interventions under investigation include: Lubiprostone (DRUG).

Who is sponsoring clinical trial NCT00669461?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00669461's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT00669461, the US trial registry maintained by the National Library of Medicine. NCT00669461 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.