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NCT01368562 · ClinicalTrials.gov registry record · NA
Compassionate Use Study of Methylnaltrexone
A NA study of Opioid-induced Constipation, sponsored by Bausch Health Americas.
- Completed
- Registry status
- NA
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT01368562: Completed NA study of Opioid-induced Constipation, sponsored by Bausch Health Americas.
NCT01368562 is a NA study of Opioid-induced Constipation that has completed, run by Bausch Health Americas. The registered enrollment target is 26 participants, below the 7,227-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01368562, a NA study of Opioid-induced Constipation, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
Primary Outcome
Opioid induced side effects included nausea, myoclonus, mental clouding (confusional state), vomiting, sedation, pruritus, sweating (hyperhidrosis), constipation, and urinary retention. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Conditions Studied
Interventions
- DRUG Methylnaltrexone
Study Locations (1)
New York
- Progenics Pharmaceuticals, Inc. - Tarrytown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2003-01-24 |
| Est. Completion | 2008-06-02 |
| Phase | NA |
What the finished NCT01368562 record still lists
NCT01368562 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 7,227-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 1 intervention - of which Methylnaltrexone is the first listed.
NCT01368562 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01368562 about?
NCT01368562 is a clinical study titled "Compassionate Use Study of Methylnaltrexone". This is an open label compassionate use study of subcutaneously administered methylnaltrexone (MNTX) in participants with advance medical illness and opioid-induced constipation.
What is the current status of trial NCT01368562?
This trial is currently completed. It is a NA study. The enrollment target is 26 participants. The study started on 2003-01-24. Estimated completion is 2008-06-02.
What conditions does trial NCT01368562 study?
This clinical trial studies the following conditions: Opioid-induced Constipation.
What interventions are being tested in trial NCT01368562?
The interventions under investigation include: Methylnaltrexone (DRUG).
Who is sponsoring clinical trial NCT01368562?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01368562 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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