NCT02290821.

Trial name or title	A randomised, 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
Methods	R, DB, PC, parallel groups
Participants	Acute blunt soft tissue injuries or contusions of the limbs, ≤ 6 hours ("fresh"). Age ≥ 16 years Estimated enrolment 200
Interventions	Diclofenac sodium gel 1% x 4 daily Placebo gel Duration of treatment not reported
Outcomes	Pain Safety
Starting date	December 2014
Contact information	Novartis
Notes	Estimated completion August 2015

AC: active control; DB: double‐blind; PC: placebo‐controlled; PGE: Patient Global Evaluation of treatment; PI: pain intensity; PID: pain intensity difference; PR: pain relief; R: randomised