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NCT00672477 · ClinicalTrials.gov registry record · Phase 4
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
A Phase 4 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 4
- Development phase
- 237
- Enrollment target
NCT00672477: Completed Phase 4 study, sponsored by Bausch Health Americas.
NCT00672477 is a Phase 4 study that has completed, run by Bausch Health Americas. The registered enrollment target is 237 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00672477, a Phase 4 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 237 participants
- Enrollment target
Study Summary
This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these subjects.
Primary Outcome
This outcome measures the proportion of subjects who had a rescue-free laxation (ie, bowel movement) within 4 hours after at least 2 of the first 4 doses of study drug. A "rescue free" laxation was defined as a laxation without use of any rescue medication or rescue procedures within 4 hours prior to the laxation.
Interventions
- DRUG Placebo
- DRUG Methylnaltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 237 participants |
| Start Date | 2008-06 |
| Est. Completion | 2013-02 |
| Phase | Phase 4 |
What the finished NCT00672477 record still lists
NCT00672477 is an interventional study that assigns participants to a tested intervention. The registered 237 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00672477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00672477 about?
NCT00672477 is a clinical study titled "Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness". This study will evaluate the safety and efficacy of methylnaltrexone administered as subcutaneous injections in subjects who have opioid-induced constipation and an advanced illness. The hypothesis is that methylnaltrexone will be safe and effective in relieving opioid-induced constipation in these ...
What is the current status of trial NCT00672477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 237 participants. The study started on 2008-06. Estimated completion is 2013-02.
What interventions are being tested in trial NCT00672477?
The interventions under investigation include: Placebo (DRUG), Methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT00672477?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00672477's enrollment target sits among peer trials
237 367th of 2000 higher than 1,634 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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