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NCT01179191 · ClinicalTrials.gov registry record · Phase 4
Conversion to Embeda With Rescue Trial
A Phase 4 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 4
- Development phase
- 684
- Enrollment target
NCT01179191: Clinical Trial Phase 4 study, sponsored by Pfizer.
NCT01179191 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 684 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01179191, a Phase 4 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 684 participants
- Enrollment target
Study Summary
The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexone hydrochloride). The study will also assess each patient's risk for prescription opioid abuse, misuse and diversion.
Primary Outcome
A dose was considered to be stable dose if it met all of the following criteria: dose was taken for at least 48 hours; investigator deemed the balance between an acceptable level of analgesia and/or function and tolerance of side effects had been achieved; and rescue medication use less than or equal to 2 doses per day.
Interventions
- DRUG morphine sulfate and naltrexone hydrochloride (EMBEDA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 684 participants |
| Start Date | 2010-08 |
| Est. Completion | 2011-04 |
| Phase | Phase 4 |
Why NCT01179191 stopped before completion
NCT01179191 is an interventional study that assigns participants to a tested intervention. The registered 684 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 1 intervention - of which morphine sulfate and naltrexone hydrochloride (EMBEDA) is the first listed.
NCT01179191 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01179191 about?
NCT01179191 is a clinical study titled "Conversion to Embeda With Rescue Trial". The purpose of the research study is to find out if opioid dependent chronic pain patients who are judged by their physician to be eligible to change their current opioid medicine and to participate in this study can be successfully adjusted to a stable dose of EMBEDA (morphine sulfate and naltrexon...
What is the current status of trial NCT01179191?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 684 participants. The study started on 2010-08. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01179191?
The interventions under investigation include: morphine sulfate and naltrexone hydrochloride (EMBEDA) (DRUG).
Who is sponsoring clinical trial NCT01179191?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01179191's enrollment target sits among peer trials
684 119th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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