At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 569 enrolled
Drug / intervention
TV-46763 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
Teva Branded Pharmaceutical Products R&D, Inc.·interventional·Posted Jul 1, 2015·Updated Mar 31, 2022
In Brief
A Phase 3 clinical trial evaluating TV-46763 and Placebo for Pain. Completed, enrolled 569 participants across 8 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
CollaboratorsSyneos Health
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartAug 2015
Primary CompletionMar 2016
TodayJul 2026
First PostedJul 1, 2015
Enrollment StartAug 11, 2015
Primary CompletionMar 30, 2016
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 11.0 years ago
Interventions
TV-46763drug
TV-46763 will be administered per dose and schedule specified in the arm description.
Placebodrug
Placebo matching to TV-46763 will be administered per schedule specified in the arm description.