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NCT00804141 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
A Phase 3 study of Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,040
- Enrollment target
- 20
- Study locations
NCT00804141: Completed Phase 3 study of Constipation, sponsored by Bausch Health Americas.
NCT00804141 is a Phase 3 study of Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 1,040 participants, above the 186-participant average among 54 other Constipation trials with a reported enrollment target (459% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00804141, a Phase 3 study of Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,040 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.
Primary Outcome
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized
Conditions Studied
Interventions
- DRUG N-methylnaltrexone bromide (MOA-728)
Study Locations (20)
Arizona
- Pfizer Investigational Site - Chandler
- Pfizer Investigational Site - Mesa
- Pfizer Investigational Site - Mesa
- Pfizer Investigational Site - Phoenix
- Pfizer Investigational Site - Phoenix
- Pfizer Investigational Site - Tempe
- Pfizer Investigational Site - Tucson
- Pfizer Investigational Site - Tucson
California
- Pfizer Investigational Site - Garden Grove
- Pfizer Investigational Site - Laguna Hills
- Pfizer Investigational Site - Los Gatos
- Pfizer Investigational Site - Newport Beach
- Pfizer Investigational Site - Newport Beach
Florida
- Pfizer Investigational Site - Boca Raton
- Pfizer Investigational Site - Brandon
- Pfizer Investigational Site - Chiefland
- Pfizer Investigational Site - Clearwater
Alabama
- Pfizer Investigational Site - Birmingham
Arkansas
- Pfizer Investigational Site - Hot Springs
Colorado
- Pfizer Investigational Site - Colorado Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,040 participants |
| Start Date | 2008-12-03 |
| Est. Completion | 2010-09-20 |
| Phase | Phase 3 |
What the finished NCT00804141 record still lists
NCT00804141 is an interventional study that assigns participants to a tested intervention. Its 1,040 participants enrollment target places it among the larger protocols in the corpus, above the 186-participant average among 54 other Constipation trials with a reported enrollment target (459% higher).
The record links to 1 condition, with Constipation appearing as the primary indexed condition, and to 1 intervention - of which N-methylnaltrexone bromide (MOA-728) is the first listed.
NCT00804141 names 20 study sites across 6 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT00804141 about?
NCT00804141 is a clinical study titled "Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation". This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week...
What is the current status of trial NCT00804141?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,040 participants. The study started on 2008-12-03. Estimated completion is 2010-09-20.
What conditions does trial NCT00804141 study?
This clinical trial studies the following conditions: Constipation.
What interventions are being tested in trial NCT00804141?
The interventions under investigation include: N-methylnaltrexone bromide (MOA-728) (DRUG).
Who is sponsoring clinical trial NCT00804141?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00804141 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Constipation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00804141's enrollment target sits among peer trials
1,040 2nd of 54 the highest of 54 other Constipation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Constipation 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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