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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets (TV-46763) at Doses of 5.0 mg/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg Every 4 to 6 Hours in Patients With Moderate to Severe Pain Following Bunionectomy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 569 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	TV-46763	TV-46763 will be administered per dose and schedule specified in the arm description.
DRUG	Placebo	Placebo matching to TV-46763 will be administered per schedule specified in the arm description.

Timeline

• Start date: 2015-08-11
• Primary completion: 2016-03-30
• Completion: 2016-03-30
• First posted: 2015-07-01
• Last updated: 2022-03-31
• Results posted: 2022-03-31

Locations

8 sites across 1 country: United States