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NCT Number: NCT02271854

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

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

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Key information

Conditions

Muscle Soreness Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lotus Clinical Research, 100 W California Blvd,

Pasadena, California, 91105, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diclofenac Sodium Gel 1%

Drug

Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).

Placebo

Drug

Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).

Primary outcomes

  1. 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

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Oct 22, 2014
Registry last updated
Apr 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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