drugset / Trial / NCT02487108
Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy
Phase 3
Completed
569 enrolled
Teva Branded Pharmaceutical Products R&D, Inc.
Syneos Health · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6 hours compared with placebo in treating participants with moderate to severe pain following bunionectomy.
Timeline
- Start
- 2015-08-11
- Primary completion
- 2016-03-30
- Completion
- 2016-03-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 325 mg | — |
| Subject | Hydrocodone | Unknown | 5 mg | — |
| Subject | Hydrocodone | Unknown | 7.5 mg | — |
| Subject | Hydrocodone | Unknown | 10 mg | — |
Indications
No indication recorded.