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

Novartis

Status and phase: Completed; Phase 3

Conditions: Ankle Sprain

Treatments: Drug: Diclofenac sodium topical gel 1%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01255423

197-P-320

Details and patient eligibility

About

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.

Enrollment: 206 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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206 participants in 2 patient groups, including a placebo group

Diclofenac sodium topical gel 1%

Experimental group

Treatment:

Drug: Diclofenac sodium topical gel 1%

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo