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

Acute Blunt Soft Tissue Injuries/Contusions Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01272947
• Other study ID #: VOSG-P-319
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2011
• Last updated: December 6, 2012
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: December 2012
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Blunt Soft Tissue Injuries/Contusions
• Contusions
• Soft Tissue Injuries

Intervention

Drug:
• Diclofenac sodium
Topical gel 1%- 4 times daily

Other:
• Placebo
Topical gel - 4 times daily

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on Movement	Visual analog scale (VAS) assessed on a 100 mm scale with anchors at 0= "No pain" and 100= "Extreme pain"	VAS Score at 24 hours	No
Secondary	Onset of Pain Relief	Onset of perceptible pain relief.	From randomization to end of day 1	No