A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Dosing Interval, Efficacy, and Safety of SST-0225, a Topical Ibuprofen Cream, in the Treatment of Delayed Onset Muscle Soreness (DOMS) (DIS DOMS)

NCT02339129 Phase 2 COMPLETED

This is a Phase 2, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the dosing interval, efficacy and safety of SST-0225 (5.4 grams, applied up to 6 times in 24 hours, over a 48-hour dosing period) for the treatment of pain associated with DOMS.

Details

Lead sponsor	Strategic Science & Technologies, LLC
Phase	Phase 2
Status	COMPLETED
Enrolment	72
Start date	2014-11
Completion	2015-03

Conditions

• Delayed Onset Muscle Soreness

Interventions

• SST-0225
• Placebo

Primary outcomes

• SPID24 (calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline) — First 24 hours after first dose
  The primary efficacy endpoint will be the time weighted summed pain/soreness intensity difference from baseline VAS pain/soreness on movement assessments over the first 24 hours (SPID24) following the first application of IP on Day 1. SPID24 will be calculated by summing the time weighted VAS pain/soreness on movement assessment differences from baseline (pre-dose on Day 1) to 24 hours (using actual reported VAS assessment times) post first dose of IP on Day 1.

Countries

United States