Phase 3
N=102
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
Muscle Soreness
Bottom Line
View on ClinicalTrials.gov: NCT02271854 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcome: Primary: Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. — 50.15; 54.83 units on a scale (NRS)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Diclofenac sodium gel 1% (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24), Derived From POW. |
50.15; 54.83 | — |
| SECONDARY Sum of Pain Intensity Differences Over 48 Hours After Initiating Treatment (SPID 48), Derived From POW. |
151.8; 160.84 | — |
Summary
This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with DOMS
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02271854). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.