Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle Sprain

Inclusion criteria: 1. Male or female aged 18 years and over. 2. Acute sprain of the lateral ankle, Grade I-II, meeting baseline pain intensity level. 3. Injury within past 12 hours. Exclusion criteria: 1. Pain medication was taken within the 6 hours that precede randomization. 2. During the past 3 months: Grade I-III sprain of the same ankle. 3. 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. 4. Pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. 5. 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