A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness

Novartis

Status and phase: Completed; Phase 3

Conditions: Muscle Soreness

Treatments: Drug: Diclofenac sodium gel 1%; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02271854

197-P-323

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 DOMS

Enrollment: 102 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 18-35 years
• Not engaged in regular lower extremity fitness activities in the past 6 months prior to screening
• Willing to refrain from use of ice, heat and massage during the study
• DOMS score ≥4 Pain at Rest (PAR) and a DOMS score ≥5 Pain on Walking (POW), with moderate or severe on categorical scale

Exclusion criteria

• Pain medication & corticosteroids prior to randomization
• Topical analgesic or anti-inflammatory treatment over the previous month
• Body mass index of >32 kg/m2

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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102 participants in 2 patient groups, including a placebo group

diclofenac sodium gel 1%

Experimental group

Description:

diclofenac sodium gel 1% applied four times daily

Treatment:

Drug: Placebo

Drug: Diclofenac sodium gel 1%

Placebo

Placebo Comparator group

Description:

Placebo gel applied four times daily

Treatment:

Drug: Placebo

Drug: Diclofenac sodium gel 1%