Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries

Novartis

Status and phase: Completed; Phase 3

Conditions: Acute Blunt Soft Tissue Injuries/Contusions

Treatments: Drug: Placebos; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02290821

197-P-322

Details and patient eligibility

About

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.

Enrollment: 215 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 16 years and over Fresh impact injury of the upper or lower limbs, not requiring admittance to hospital & meeting baseline pain intensity level Anticipated time between injury and treatment must be ≤ 6 hours

Exclusion criteria

• Pain medication prior to randomization Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated Any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities 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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215 participants in 2 patient groups, including a placebo group

diclofenac sodium gel 1%

Experimental group

Description:

diclofenac sodium gel 1%

Treatment:

Drug: placebo

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebos