Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Completed · Phase 3 · Has a placebo group
Conditions studied: Ankle Sprain
In brief
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.
Key facts
- Study ID
- NCT01255423
- Run by
- Novartis
- People needed
- 206
- Starts
- 2010-11-01
- Expected to finish
- 2011-06-01
- Last updated by the study team
- 2012-10-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged 18 years and over.
- Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level.
- Injury within past 12 hours.
You may not qualify if…
- Pain medication was taken within the 6 hours that precede randomization.
- During the past 3 months: Grade I-III sprain of the same ankle.
- During the past 6 months: Grade II-III sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot.
- Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma.
- Ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., Marfan's syndrome, Down's syndrome, Ehlers-Danlos syndrome).
- Other protocol-defined inclusion/exclusion criteria may apply
Where it is running
- Study site — Birmingham, Alabama, United States
- Study site — Aventura, Florida, United States
- Study site — Hialeah, Florida, United States
- Study site — Miami, Florida, United States
- Study site — Berlin, New Jersey, United States
- Study site — Columbia, South Carolina, United States
- Study site — El Paso, Texas, United States
- Study site — Houston, Texas, United States
- Study site — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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