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NCT00908076 · ClinicalTrials.gov registry record · Phase 4
Amitiza in Constipation Associated With PD (Parkinson's Disease)
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 78
- Enrollment target
NCT00908076: Completed Phase 4 study, sponsored by Baylor College of Medicine.
NCT00908076 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 78 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00908076, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 78 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, quality of life and motor symptoms.
Primary Outcome
Global impression of change, stool diary, visual analog scale of improvement, UPDRS rating scale and constipation questionnaires. The primary efficacy data will be analyzed using Student's t-test with unequal variances as the difference from baseline in SBM comparing cases and controls, using last observation carried forward for missing data in the intent-to-treat population.
Interventions
- DRUG LUBIPROSTONE
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2009-02 |
| Est. Completion | 2010-10 |
| Phase | Phase 4 |
What the finished NCT00908076 record still lists
NCT00908076 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which LUBIPROSTONE is the first listed.
NCT00908076 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00908076 about?
NCT00908076 is a clinical study titled "Amitiza in Constipation Associated With PD (Parkinson's Disease)". The purpose of this study is to determine if Amitiza (lubiprostone), a drug proven to be safe and effective for chronic constipation, will also improve constipation symptoms in Parkinson's Disease patients. We will also evaluate the impact of the drug on changes in bowel movement consistency, qualit...
What is the current status of trial NCT00908076?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 78 participants. The study started on 2009-02. Estimated completion is 2010-10.
What interventions are being tested in trial NCT00908076?
The interventions under investigation include: LUBIPROSTONE (DRUG).
Who is sponsoring clinical trial NCT00908076?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00908076's enrollment target sits among peer trials
78 982nd of 2000 higher than 1,012 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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