Phase 3
N=206
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain
Ankle Sprain
Bottom Line
View on ClinicalTrials.gov: NCT01255423 ↗Enrolled (actual)
206
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Pain on Movement — 37.4; 38.8 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diclofenac sodium topical gel 1% (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain on Movement |
52.9; 53.1; 19.4; 22 | — |
| SECONDARY Pain on Movement |
52.9; 53.1; 19.4; 22 | — |
| SECONDARY Onset of Pain Relief |
2; 2 | — |
| SECONDARY Tenderness |
2.3; 1.3; 6.4; 5.5; 12.1; 11.9 | — |
| SECONDARY Ankle Joint Function |
30.1; 30.7; 47.2; 46.1; 68.8; 66.4 | — |
Summary
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.
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01255423). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.