Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

Acute Blunt Soft Tissue Injuries/Contusions Clinical Trial

Official title:

A Randomized, Double-blind, 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: NCT02290821
• Other study ID #: 197-P-322
• Status: Completed
• Phase: Phase 3
• First received: November 11, 2014
• Last updated: November 23, 2015
• Start date: December 2014
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Male or female subjects aged 16 years and over Fresh impact injury of the upper or lower limbs, not requiring admittance to hospital & meeting baseline pain intensity level Anticipated time between injury and treatment must be = 6 hours

Exclusion Criteria:

• Pain medication prior to randomization Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated Any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• diclofenac sodium gel 1%

Locations

Country	Name	City	State
United States	US Site	Bellaine	Texas
United States	US Site	Boise	Idaho
United States	US Site	Bradenton	Florida
United States	US Site	Brooklyn	New York
United States	US Site	Columbus	Ohio
United States	US Site	Grand Rapids	Michigan
United States	US Site	Houston	Texas
United States	US Site	Omaha	Nebraska
United States	US Site	Port Orange	Florida
United States	US Site	State College	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24)		24 hours	No