Status:
COMPLETED
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Lead Sponsor:
Novartis
Conditions:
Acute Blunt Soft Tissue Injuries/Contusions
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT02290821
Start Date
December 1 2014
End Date
September 1 2015
Last Update
April 19 2017
Active Locations (10)
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1
US Site
Bradenton, Florida, United States
2
US Site
Port Orange, Florida, United States
3
US Site
Boise, Idaho, United States
4
US Site
Grand Rapids, Michigan, United States