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
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 gel applied four times daily
Intervention: Diclofenac sodium gel 1% (Drug)
diclofenac sodium gel 1%
diclofenac sodium gel 1% applied four times daily
Intervention: Diclofenac sodium gel 1% (Drug)
diclofenac sodium gel 1%
diclofenac sodium gel 1% applied four times daily
Intervention: Placebo (Drug)
Placebo
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)