Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain

Novartis

Status and phase: Completed; Phase 2

Conditions: Ankle Sprain

Treatments: Drug: Placebo; Drug: Diclofenac diethylamine 2.32% gel; Drug: Diclofenac diethylamine 2.32% gel / Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00573768

VOPO-PE-201

Details and patient eligibility

About

This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment of acute ankle sprain.

Enrollment: 271 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute sprain of the ankle
• Injury within past 48 hours.

Exclusion criteria

• Pain medication taken since the injury
• Pain or instability in the same ankle due to previous ankle sprain or any other trauma.
• Ankle sprain due to a known disease affecting the ligaments

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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271 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Treatment:

Drug: Diclofenac diethylamine 2.32% gel

2

Placebo Comparator group

Treatment:

Drug: Placebo

3

Active Comparator group

Treatment:

Drug: Diclofenac diethylamine 2.32% gel / Placebo