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Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy

NCT02487108 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 569

Last updated 2022-03-31

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-11
Primary Completion
2016-03-30
Completion
2016-03-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02487108 on ClinicalTrials.gov