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NCT00401362 · ClinicalTrials.gov registry record · Phase 3
A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients
A Phase 3 study of Advanced Illness Patients With Opioid Induced Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT00401362: Completed Phase 3 study of Advanced Illness Patients With Opioid Induced Constipation, sponsored by Bausch Health Americas.
NCT00401362 is a Phase 3 study of Advanced Illness Patients With Opioid Induced Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 154 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00401362, a Phase 3 study of Advanced Illness Patients With Opioid Induced Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
Study Summary
To test the effectiveness of MNTX in advanced illness subjects.
Primary Outcome
The primary objective is to determine the efficacy of SC MNTX administered as a single dose, dose 1 and dose 2 compared with placebo in inducing laxation in 4 hours in patients with advanced medical illness and OIC who are poorly responsive to laxatives.
Conditions Studied
Interventions
- DRUG SC Placebo
- DRUG SC Methylnaltrexone
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2003-02 |
| Est. Completion | 2005-02 |
| Phase | Phase 3 |
What the finished NCT00401362 record still lists
NCT00401362 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Advanced Illness Patients With Opioid Induced Constipation appearing as the primary indexed condition, and to 2 interventions - of which SC Placebo is the first listed.
NCT00401362 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00401362 about?
NCT00401362 is a clinical study titled "A a Single Dose Efficacy Study in Inducing Laxation in Advance Illness Patients". To test the effectiveness of MNTX in advanced illness subjects.
What is the current status of trial NCT00401362?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 154 participants. The study started on 2003-02. Estimated completion is 2005-02.
What conditions does trial NCT00401362 study?
This clinical trial studies the following conditions: Advanced Illness Patients With Opioid Induced Constipation.
What interventions are being tested in trial NCT00401362?
The interventions under investigation include: SC Placebo (DRUG), SC Methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT00401362?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00401362 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00401362's enrollment target sits among peer trials
154 1509th of 2000 higher than 491 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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