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Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain

NCT02101554 ↗

Phase 4 Terminated 19 enrolled Pfizer
Open-labelTreatment

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.

Timeline

Start
2015-04-24
Primary completion
2019-06-26
Completion
2019-06-26

Outcome

Outcome not reported

Stopped: “Pfizer released from post-marketing commitment and study terminated because too few patients in the age group; not because of efficacy or safety issues.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Morphine Other / unclassified — Oral

Indications

No indication recorded.