drugset
drugset / Trial / NCT01922739

Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets

NCT01922739 ↗

Phase 3 Completed 182 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This is a 6-month, nonrandomized, open-label extension study to assess the long-term safety of hydrocodone bitartrate extended-release (ER) tablets in patients with moderate to severe chronic low back pain who require continuous opioid treatment for an extended period of time. To be eligible for Study 3104, patients were required to have completed the entire double blind treatment period on study drug (either placebo or hydrocodone bitartrate ER tablets) through week 12 of Study 3103 (NCT01789970) and to have met the entry criteria for Study 3104.

Timeline

Start
2013-07
Primary completion
2014-08
Completion
2014-08

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

No indication recorded.