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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: January 7, 2011
Last updated: December 6, 2012
Last verified: December 2012
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

Condition Intervention Phase
Acute Blunt Soft Tissue Injuries/Contusions
Drug: Diclofenac sodium
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center, 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pain on Movement [ Time Frame: 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:
  • Onset of Pain Relief [ Time Frame: From randomization to end of day 1 ]
    Onset of perceptible pain relief.

Enrollment: 204
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac sodium topical gel 1% Drug: Diclofenac sodium
Topical gel 1%- 4 times daily
Placebo Comparator: placebo Other: Placebo
Topical gel - 4 times daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01272947

NCH investigative site
Brühl, Germany
NCH investigative site
Butzbach, Germany
NCH investigative site
Cologne, Germany
NCH investigative site
Essen, Germany
NCH investigative site
Gilching, Germany
NCH investigative site
Munich, Germany
Sponsors and Collaborators
  More Information

Responsible Party: Novartis Identifier: NCT01272947     History of Changes
Other Study ID Numbers: VOSG-P-319
Study First Received: January 7, 2011
Results First Received: July 17, 2012
Last Updated: December 6, 2012

Keywords provided by Novartis:
Blunt soft tissue injury/contusion

Additional relevant MeSH terms:
Wounds and Injuries
Soft Tissue Injuries
Wounds, Nonpenetrating
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 24, 2017