Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
NCT00672139 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00672139
The ClinicalTrials.gov registry entry for NCT00672139 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00672139 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00672139?
The interventions under investigation include: Methylnaltrexone bromide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00672139?
This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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