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NCT01367561 · ClinicalTrials.gov registry record · Phase 1
Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function
A Phase 1 study of Healthy Males, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT01367561: Completed Phase 1 study of Healthy Males, sponsored by Bausch Health Americas.
NCT01367561 is a Phase 1 study of Healthy Males that has completed, run by Bausch Health Americas. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01367561, a Phase 1 study of Healthy Males, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
Primary Outcome
To investigate the potential benefit of methylnaltrexone in preventing or treating opioid-induced urinary retention.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Naloxone
- DRUG IV Methylnaltrexone (MNTX)
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2002-10 |
| Est. Completion | 2003-05 |
| Phase | Phase 1 |
What the finished NCT01367561 record still lists
NCT01367561 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Healthy Males appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01367561 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01367561 about?
NCT01367561 is a clinical study titled "Naloxone and Intravenous Methylnaltrexone Effects on Bladder Function". This is a double-blind, randomized, study at a single clinical site investigating the effect of methylnaltrexone and naloxone versus placebo in healthy males who have received a short-acting opioid, remifentanil.
What is the current status of trial NCT01367561?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2002-10. Estimated completion is 2003-05.
What conditions does trial NCT01367561 study?
This clinical trial studies the following conditions: Healthy Males.
What interventions are being tested in trial NCT01367561?
The interventions under investigation include: Placebo (DRUG), Naloxone (DRUG), IV Methylnaltrexone (MNTX) (DRUG).
Who is sponsoring clinical trial NCT01367561?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01367561 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
Similar trials for Healthy Males
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 NCT01367561's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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