Conditions: Dental Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 202
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.

Detailed description:

Arms:
arm 1: One 18-mg Diclofenac Test Capsule and 1 placebo capsule arm 2: One 35-mg Diclofenac Test Capsule and 1 placebo capsule arm 3: None arm 4: None

Interventions: intervention 1: Diclofenac Test (lower dose) intervention 2: Diclofenac Test (upper dose) intervention 3: Celecoxib 400 mg intervention 4: Placebo
Intervention descriptions: intervention 1: 18-mg Single dose intervention 2: 35-mg Single dose intervention 3: Capsules 2 x 200 mg Single-dose intervention 4: Capsules 2 Single-dose

Protocol document: