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

January 7, 2011
December 6, 2012
January 2011
July 2011   (final data collection date for primary outcome measure)
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"
Pain on movement [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01272947 on ClinicalTrials.gov Archive Site
Onset of Pain Relief [ Time Frame: From randomization to end of day 1 ] [ Designated as safety issue: No ]
Onset of perceptible pain relief.
Onset of pain relief [ Time Frame: On day 1 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied Four Times Daily in Subjects With Acute Blunt Trauma Injuries
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Blunt Soft Tissue Injuries/Contusions
  • Drug: Diclofenac sodium
    Topical gel 1%- 4 times daily
  • Other: Placebo
    Topical gel - 4 times daily
  • Experimental: Diclofenac sodium topical gel 1%
    Intervention: Drug: Diclofenac sodium
  • Placebo Comparator: placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
204
July 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01272947
VOSG-P-319
No
Novartis
Novartis
Not Provided
Not Provided
Novartis
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP