Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain

Novartis

Status and phase: Completed; Phase 3

Conditions: Grade I/II Ankle Sprain

Treatments: Drug: Placebo; Drug: diclofenac diethylamine gel 2.32%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00955513

VOPO-P-307

Details and patient eligibility

About

The main purpose of this trial is to compare the efficacy and safety of diclofenac diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in the treatment of acute ankle sprains (distortions).

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Acute sprain of the lateral ankle, Grade I-II .

Exclusion criteria

1. Any concurrent injury affecting the lower extremities that is painful at rest or on movement, or could affect the mobilization of the patient.
2. Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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242 participants in 3 patient groups, including a placebo group

diclofenac diethylamine gel 2.32% gel twice a day

Experimental group

Description:

drug

Treatment:

Drug: diclofenac diethylamine gel 2.32%

Drug: diclofenac diethylamine gel 2.32%

diclofenac diethylamine gel 2.32% gel three times a day

Experimental group

Description:

drug

Treatment:

Drug: diclofenac diethylamine gel 2.32%

Drug: diclofenac diethylamine gel 2.32%

placebo

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo