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

Muscle Soreness Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness (DOMS) of the Lower Limbs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271854
• Other study ID #: 197-P-323
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2014
• Last updated: January 29, 2015
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Soreness
• Myalgia

Intervention

Drug:
• Diclofenac sodium gel 1%
Diclofenac sodium gel 1% four times daily

Locations

Country	Name	City	State
United States	Lotus Clinical Research, 100 W California Blvd,	Pasadena,	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24), derived from POW.		24 hours	No
Secondary	Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48), derived from POW.		48 hours	No