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Clinical Trials/NCT02271854
NCT02271854CompletedPhase 3

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

Novartis1 site in 1 country102 target enrollmentStarted: October 2014Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Sponsor
Novartis
Enrollment
102
Locations
1
Primary Endpoint
Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Placebo

Placebo Comparator

Placebo gel applied four times daily

Intervention: Diclofenac sodium gel 1% (Drug)

diclofenac sodium gel 1%

Experimental

diclofenac sodium gel 1% applied four times daily

Intervention: Diclofenac sodium gel 1% (Drug)

diclofenac sodium gel 1%

Experimental

diclofenac sodium gel 1% applied four times daily

Intervention: Placebo (Drug)

Placebo

Placebo Comparator

Placebo gel applied four times daily

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW.

Time Frame: 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 Outcomes

  • Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW.(48 hours)

Investigators

Sponsor
Novartis
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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