drugset
drugset / Trial / NCT01789970

Efficacy and Safety of Hydrocodone Bitartrate Extended-Release Tablets for Moderate to Severe Chronic Low Back Pain

NCT01789970 ↗

Phase 3 Completed 625 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to evaluate the efficacy of hydrocodone bitartrate extended-release tablets at doses of 30 to 90 mg every 12 hours compared with placebo in alleviating moderate to severe pain in patients with chronic low back pain. Patients may be opioid-naïve or opioid-experienced.

Timeline

Start
2013-03
Primary completion
2014-02
Completion
2014-02

Drugs

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

Indications

No indication recorded.