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

Novartis

Status and phase: Completed; Phase 4

Conditions: Neck Pain

Treatments: Drug: Placebo gel; Drug: Diclofenac diethylamine 1.16% gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01335724

862-P-201

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Diclofenac diethylamine 1.16% gel

Experimental group

Treatment:

Drug: Diclofenac diethylamine 1.16% gel

placebo gel

Placebo Comparator group

Treatment:

Drug: Placebo gel