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

• ClinicalTrials.gov Identifier: NCT02271854
• Recruitment Status: Completed
• First Posted: October 22, 2014
• Results First Posted: April 5, 2016
• Last Update Posted: April 5, 2016
• Sponsor: Novartis
• Information provided by (Responsible Party): Novartis

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Muscle Soreness	Drug: Diclofenac sodium gel 1%; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: October 2014
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: diclofenac sodium gel 1%; diclofenac sodium gel 1% applied four times daily	Drug: Diclofenac sodium gel 1%; 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).; Drug: Placebo; 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).
Placebo Comparator: Placebo; Placebo gel applied four times daily	Drug: Diclofenac sodium gel 1%; 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).; Drug: Placebo; 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 35 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Lotus Clinical Research, 100 W California Blvd,

Pasadena,, California, United States, 91105

Sponsors and Collaborators

Novartis

More Information

• Responsible Party: Novartis
• ClinicalTrials.gov Identifier: NCT02271854
• Other Study ID Numbers: 197-P-323
• First Posted: October 22, 2014
• Results First Posted: April 5, 2016
• Last Update Posted: April 5, 2016
• Last Verified: March 2016

Additional relevant MeSH terms:

Myalgia; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Diclofenac; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action