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

PHASE3CompletedINTERVENTIONAL
Enrollment

569

Participants

Timeline

Start Date

August 11, 2015

Primary Completion Date

March 30, 2016

Study Completion Date

March 30, 2016

Conditions
Pain
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.

Trial Locations (8)

21122

Teva Investigational Site 13169, Pasadena

78229

Teva Investigational Site 13172, San Antonio

84124

Teva Investigational Site 13171, Salt Lake City

84790

Teva Investigational Site 13511, St. George

85023

Teva Investigational Site 13510, Phoenix

91105

Teva Investigational Site 13170, Pasadena

92801

Teva Investigational Site 13173, Anaheim

93311

Teva Investigational Site 13174, Bakersfield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY