Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 16 - Any |
| Updated: | 4/21/2016 |
| Start Date: | December 2014 |
| End Date: | September 2015 |
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Blunt Soft Tissue Injuries/Contusions of the Limbs
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction
of the pain associated with acute blunt trauma injuries.
of the pain associated with acute blunt trauma injuries.
Inclusion Criteria:
- Male or female subjects aged 16 years and over Fresh impact injury of the upper or
lower limbs, not requiring admittance to hospital & meeting baseline pain intensity
level Anticipated time between injury and treatment must be ≤ 6 hours
Exclusion Criteria:
- Pain medication prior to randomization Topical analgesic or anti-inflammatory
treatment over the previous month in the area to be treated Any physical impairment
that would influence efficacy assessments, such as peripheral or central neurological
disease, significant back pain, painful conditions of the upper or lower extremities
Other protocol-defined inclusion/exclusion criteria may apply
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