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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.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01272947
First received: January 7, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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 (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Pain on Movement [ Time Frame: VAS Score at 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272947

Locations
Germany
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
Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov 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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by Novartis:
Blunt soft tissue injury/contusion

Additional relevant MeSH terms:
Contusions
Soft Tissue Injuries
Wounds and Injuries
Wounds, Nonpenetrating
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013