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

Phase 3

Completed

• Conditions: Muscle Soreness
• Interventions: Drug: Diclofenac sodium gel 1%; Drug: Placebo

• Registration Number: NCT02271854
• Lead Sponsor: Novartis

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-20
• Study First Submitted QC: 2014-10-20
• Study First Posted: 2014-10-22
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-12-15
• Status Verified: 2016-03
• Results First Submitted QC: 2016-03-07
• Last Update Submitted: 2016-03-07
• Results First Posted: 2016-04-05
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Placebo	Diclofenac sodium gel 1%	Placebo gel applied four times daily
diclofenac sodium gel 1%	Diclofenac sodium gel 1%	diclofenac sodium gel 1% applied four times daily
diclofenac sodium gel 1%	Placebo	diclofenac sodium gel 1% applied four times daily
Placebo	Placebo	Placebo gel applied four times daily

Primary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.	24 hours	The primary efficacy outcome was the time-weighted SPID 24 (POW). Sum of pain intensity differences over 24 hours after initiating treatment (SPID 24) for the modified ITT population. SPID 24 derived from Pain on Walking (POW) scores assessed over 24 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 24 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.

Secondary Outcome Measures

Name	Time	Method
Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.	48 hours	Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) (POW) was a secondary outcome.; Sum of pain intensity differences over 48 hours after initiating treatment (SPID 48) for the modified ITT population. SPID 48 derived from Pain on Walking (POW) scores assessed over 48 hours on a 0 (No pain) - 10 (Pain as bad as you can imagine) Numerical Rating Scale. SPID 48 was computed using the trapezoidal rule, i.e. Σ \[T(i) - T(i-1)\] x \[((PID)(i-1) + PID(i))/2\] in an obvious notation, where T(i) is nominal time and PID(i), the pain intensity difference at Time i, is the baseline pain intensity (PI) score - PI score at Time i.

Trial Locations

Locations (1)

Lotus Clinical Research, 100 W California Blvd,; 🇺🇸 Pasadena,, California, United States