Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.

PHASE3CompletedINTERVENTIONAL
Enrollment

637

Participants

Timeline

Start Date

March 14, 2017

Primary Completion Date

November 9, 2017

Study Completion Date

November 28, 2017

Conditions
Acute Post-surgical Pain
Interventions
DRUG

Co-crystal E-58425 (Tramadol/Celecoxib)

Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.

DRUG

Tramadol (Ultram®)

Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.

DRUG

Celecoxib (Celebrex®)

Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.

DRUG

Placebo

Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.

Trial Locations (5)

21122

Chesapeake Research Group, LLC, Pasadena

78705

Optimal Research, LLC, Austin

84124

Jean Brown Research, Salt Lake City

85023

Arizona Research Center, Phoenix

92801

Anaheim Clinical Trials, LLC, Anaheim

Sponsors
All Listed Sponsors
collaborator

Premier Research Group plc

UNKNOWN

lead

Laboratorios del Dr. Esteve, S.A.

INDUSTRY

NCT03108482 - Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial. | Biotech Hunter | Biotech Hunter