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NCT02101554 · ClinicalTrials.gov registry record · Phase 4
Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain
A Phase 4 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 4
- Development phase
- 19
- Enrollment target
NCT02101554: Clinical Trial Phase 4 study, sponsored by Pfizer.
NCT02101554 is a Phase 4 study that was terminated before completion, run by Pfizer. The registered enrollment target is 19 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02101554, a Phase 4 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 19 participants
- Enrollment target
Study Summary
Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
Primary Outcome
An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. A treatment emergent AE was defined as an event that emerged during the tre
Interventions
- DRUG Ages 7-11
- DRUG ages 12-17
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2015-04-24 |
| Est. Completion | 2019-06-26 |
| Phase | Phase 4 |
Why NCT02101554 stopped before completion
NCT02101554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Ages 7-11 is the first listed.
NCT02101554 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02101554 about?
NCT02101554 is a clinical study titled "Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain". Safety and pharmacokinetics of an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core in children 7-17 with moderate-severe pain.
What is the current status of trial NCT02101554?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 19 participants. The study started on 2015-04-24. Estimated completion is 2019-06-26.
What interventions are being tested in trial NCT02101554?
The interventions under investigation include: Ages 7-11 (DRUG), ages 12-17 (DRUG).
Who is sponsoring clinical trial NCT02101554?
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 NCT02101554's enrollment target sits among peer trials
19 1834th of 2000 higher than 159 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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