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NCT00672139 · ClinicalTrials.gov registry record · Phase 4
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
A Phase 4 study of Opioid-induced Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 4
- Development phase
- 156
- Enrollment target
- 20
- Study locations
NCT00672139: Completed Phase 4 study of Opioid-induced Constipation, sponsored by Bausch Health Americas.
NCT00672139 is a Phase 4 study of Opioid-induced Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 156 participants, below the 7,201-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00672139, a Phase 4 study of Opioid-induced Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 156 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This study will last 3 months.
Primary Outcome
This was defined as the total number of days with a laxation (ie, a bowel movement) within 24 hours after dosing in each 7-day interval after the start of dosing. Results shown are the ranges (lowest and highest weekly values) of mean (± standard deviation) numbers of laxations within 24 hours of dosing per week during the 10-week treatment period for each group.
Conditions Studied
Interventions
- DRUG Methylnaltrexone bromide
Study Locations (20)
Florida
- Salix Investigational Site - Auburndale
- Salix Investigational Site - Hudson
- Salix Investigational Site - Lakeland
- Salix Investigational Site - Lakeland
- Salix Investigational Site - Miami Springs
- Salix Investigational Site - Ruskin
- Salix Investigational Site - Sebring
- Salix Investigational Site - Tampa
- Salix Investigational Site - Tampa
- Salix Investigational Site - Tampa
- Salix Investigational Site - Temple Terrace
California
- Salix Investigational Site - Laguna Hills
- Salix Investigational Site - Lancaster
North Carolina
- Salix Investigational Site - Flat Rock
- Salix Investigational Site - Winston-Salem
Alabama
- Salix Investigational Site - Mobile
Colorado
- Salix Investigational Site - Aurora
New Jersey
- Salix Investigational Site - Orange
Ohio
- Salix Investigational Site - Cleveland
Pennsylvania
- Salix Investigational Site - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2008-07 |
| Est. Completion | 2013-05 |
| Phase | Phase 4 |
What the finished NCT00672139 record still lists
NCT00672139 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 7,201-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 1 intervention - of which Methylnaltrexone bromide is the first listed.
NCT00672139 names 20 study sites across 8 states, led by Florida, California, North Carolina.
Frequently Asked Questions
What is clinical trial NCT00672139 about?
NCT00672139 is a clinical study titled "Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness". This is an open-label, multicenter extension of study 3200K1-4000-WW that will evaluate the safety of methylnaltrexone. This drug will be administered by subcutaneous injection and will be tested in late stage, advanced illness patients who have constipation caused by opioid pain relievers. This stu...
What is the current status of trial NCT00672139?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 156 participants. The study started on 2008-07. Estimated completion is 2013-05.
What conditions does trial NCT00672139 study?
This clinical trial studies the following conditions: Opioid-induced Constipation.
What interventions are being tested in trial NCT00672139?
The interventions under investigation include: Methylnaltrexone bromide (DRUG).
Who is sponsoring clinical trial NCT00672139?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00672139 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Florida, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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