CompletedPhase 2

Controlled Study to Assess the Efficacy and Safety of S-Ibuprofen Topical Gel 5% (AP0302) in the Treatment of DOMS

United States251 participantsStarted 2018-01-12

Plain-language summary

Phase 2 study designed to evaluated analgesic efficacy and safety of S-Ibuprofen Topical Gel 5%

Who can participate

Age range18 Years – 55 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * history of pain/soreness after exercise * BMI between 18-30 * negative drug, alcohol, pregnancy screens * other protocol-defined inclusion criteria may apply Exclusion Criteria: * upper extremity workout in last 3 months * job or hobby requiring heavy lifting * history of muscle disorders * allergy or intolerance to NSAID or study drug * history of recent pain medication use * other protocol-defined exclusion criteria may apply

What they're measuring

Sum of the Time-weighted Differences From Baseline in Pain Intensity With Movement(SPIDMOVE) Over 24 Hours Post Time Zero

Timeframe: 0-24 hours.

Trial details

NCT IDNCT03852459

SponsorAponia Laboratories, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-04-04

Results submitted2021-04-19

View on ClinicalTrials.gov More Pain, Acute trials