Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Potassium 25 mg Tablet Taken Three Times Daily in Subjects With Acute Joint Pain

The purpose of this study is to evaluate the efficacy of diclofenac potassium 25 mg tablet compared with placebo taken three times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

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).