Tramadol/Diclofenac Fixed-dose Combination Phase III Trial in Acute Pain After Third Molar Extraction

PHASE3CompletedINTERVENTIONAL
Enrollment

1,151

Participants

Timeline

Start Date

August 26, 2017

Primary Completion Date

March 9, 2018

Study Completion Date

March 22, 2018

Conditions
Acute Pain
Interventions
DRUG

Tramadol/Diclofenac 50/50

Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.

DRUG

Tramadol/Diclofenac 25/25

Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.

DRUG

Tramadol 50

Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart.

DRUG

Diclofenac 50

Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.

Trial Locations (8)

CP 45030

Private Clinic, Zapopan

CP 64000

Private Clinic, Monterrey

CP 64718

Private Clinic, Monterrey

CP 20230

Private Clinic, Aguascalientes

CP 31203

Private Clinic, Chihuahua City

CP 37160

Private Clinic, León

CP 72160

Private Clinic, Puebla City

CP 78290

University, San Luis Potosí City

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Grünenthal, S.A.

INDUSTRY

lead

Grünenthal GmbH

INDUSTRY