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NCT01100437 · ClinicalTrials.gov registry record · Phase 4
Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients
A Phase 4 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 4
- Development phase
- 14
- Enrollment target
NCT01100437: Clinical Trial Phase 4 study, sponsored by Pfizer.
NCT01100437 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01100437, a Phase 4 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 14 participants
- Enrollment target
Study Summary
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
Primary Outcome
COWS is an 11 section clinical assessment of withdrawal symptoms, each section is rated from 0 (no symptom) to 4 or 5 (most severe symptom). Total score is classified into a 4 point rating scale (mild 5-12, moderate 13-24, moderately severe 25-36 and severe more than 36 points).
Interventions
- DRUG EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush
- DRUG EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2010-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 4 |
Why NCT01100437 stopped before completion
NCT01100437 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush is the first listed.
NCT01100437 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01100437 about?
NCT01100437 is a clinical study titled "Safety Study to Assess Opiate Withdrawal Signs and Symptoms in Opioid Dependent Patients". This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
What is the current status of trial NCT01100437?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2010-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT01100437?
The interventions under investigation include: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush (DRUG), EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole (DRUG).
Who is sponsoring clinical trial NCT01100437?
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 NCT01100437's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 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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