Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries

Phase 3

Completed

• Conditions: Acute Blunt Soft Tissue Injuries/Contusions
• Interventions: Drug: Diclofenac sodium; Other: Placebo

• Registration Number: NCT01272947
• Lead Sponsor: Novartis

Brief Summary

The purpose of this study is to evaluate the efficacy of DSG 1% compared with placebo applied four times a day in subjects with acute blunt soft tissue injuries/contusions of the limbs

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-01-07
• Study First Posted: 2011-01-10
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Results First Submitted: 2012-07-17
• Status Verified: 2012-12
• Results First Submitted QC: 2012-12-06
• Last Update Submitted: 2012-12-06
• Results First Posted: 2013-01-10
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Male or female aged 18 years and over.
• Fresh impact injury (blunt, traumatic soft tissue injury or contusion) of the upper or the lower limbs, not requiring admittance to hospital, meeting baseline pain intensity level.Anticipated time between injury and treatment must be less than 3 hours.

Exclusion Criteria

• Pain medication was taken within the 6 hours that precede randomization.Any physical impairment that would influence the study's efficacy evaluations, in particular POM such as: peripheral or central neurological disease, significant back pain; in case of acute blunt soft tissue injuries of the lower limbs: symptomatic osteoarthritis of the hips, knees, or feet, or any other painful conditions of the lower extremities (e.g., painful nail, wound, corn, or wart), in case of acute blunt soft tissue injuries of the upper limbs: no painful conditions of the upper extremities.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac sodium topical gel 1%	Diclofenac sodium	-
placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Pain on Movement	VAS Score at 24 hours	Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"

Secondary Outcome Measures

Name	Time	Method
Onset of Pain Relief	From randomization to end of day 1	Onset of perceptible pain relief.

Trial Locations

Locations (1)

NCH investigative site; 🇩🇪 Munich, Germany