drugset
drugset / Trial / NCT01223365

Study to Evaluate the Long-Term Safety of Hydrocodone Bitartrate Extended-Release Tablets (CEP-33237) in Patients Who Require Opioid Treatment for an Extended Period of Time

NCT01223365 ↗

Phase 3 Completed 330 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the safety of hydrocodone extended-release tablets when used over a 12-month period in patients with chronic pain, as assessed by adverse events, clinical laboratory results, vital signs measurements, electrocardiogram results, physical examination findings, pure tone audiometry, and concomitant medication usage.

Timeline

Start
2010-10
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocodone ER Unknown 15 mg Oral
Subject Hydrocodone ER Unknown 30 mg Oral
Subject Hydrocodone ER Unknown 45 mg Oral
Subject Hydrocodone ER Unknown 60 mg Oral
Subject Hydrocodone ER Unknown 90 mg Oral

Indications

chronic pain syndrome