Open-Label, Extension Study to Evaluate the Safety of Hydrocodone Bitartrate Extended-Release Tablets
Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc. Teva Pharmaceutical Industries