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drugset / Trial / NCT02222740

A Safety, Tolerability and Pharmacokinetic Dose Escalation Study of HC-ER in Patients With Osteoarthritis Pain

NCT02222740 ↗

Phase 2 Completed 37 enrolled Zogenix, Inc.
Non-randomizedParallel-groupOpen-labelOther

Summary

Assess the safety, tolerability and pharmacokinetics of multiple doses of 10, 20, 30, and 40 mg of Hydrocodone Bitartrate Extended Release (HC-ER)capsules taken with food at steady state, in subjects with chronic, moderate to severe osteoarthritis (OA) pain.

Timeline

Start
2002-09
Primary completion
2002-12
Completion
2002-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocodone ER Unknown 30 mg —
Subject Hydrocodone ER Unknown 40 mg —

Indications

osteoarthritis