Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

A Randomized, Double-blind, Placebo-controlled, Multi-center Parallel Group Phase IV Study to Evaluate the Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck Pain

The purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.

Inclusion Criteria:

• Male or female subjects, age range 18 and over.
• Patient with acute neck pain meeting baseline pain intensity level and duration

Exclusion Criteria:

• Pain medication was taken within the 6 hours that precede randomization.
• Patient with chronic neck pain as defined as pain for 3 months or longer
• Any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors.
• Any recent strains of the neck muscles documented by the clinical evaluation and anamnesis