Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Completed · Phase 3 · Has a placebo group
Conditions studied: Acute Blunt Soft Tissue Injuries/Contusions
In brief
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.
Key facts
- Study ID
- NCT02290821
- Run by
- Novartis
- People needed
- 215
- Starts
- 2014-12-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-04-19
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- US Site — Bradenton, Florida, United States
- US Site — Port Orange, Florida, United States
- US Site — Boise, Idaho, United States
- US Site — Grand Rapids, Michigan, United States
- US Site — Omaha, Nebraska, United States
- US Site — Brooklyn, New York, United States
- US Site — Columbus, Ohio, United States
- US Site — State College, Pennsylvania, United States
- US Site — Bellaine, Texas, United States
- US Site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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