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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:
ClinicalTrials.gov Identifier:
NCT01272947
First Posted: January 10, 2011
Last Update Posted: January 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  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: Quadruple (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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01272947     History of Changes
Other Study ID Numbers: VOSG-P-319
First Submitted: January 7, 2011
First Posted: January 10, 2011
Results First Submitted: July 17, 2012
Results First Posted: January 10, 2013
Last Update Posted: January 10, 2013
Last Verified: December 2012

Keywords provided by Novartis:
Blunt soft tissue injury/contusion

Additional relevant MeSH terms:
Wounds and Injuries
Soft Tissue Injuries
Contusions
Wounds, Nonpenetrating
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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