Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness (DOMS)

Phase 3

Completed

Brief Summary: This is a Phase 3, prospective, randomized, dual-center, double-blind, placebo-controlled, parallel-group study designed to determine the 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.

Detailed Description: This is a Phase 3, prospective, randomized, multicenter, double blind, placebo controlled, parallel group study designed to determine the efficacy and safety of SST-0225 for the treatment of pain associated with DOMS. Healthy volunteers will be recruited to undergo an exercise regimen designed to induce DOMS in the elbow flexor of the non-dominant arm. Subjects who are eligible following the exercise regimen will be randomized to receive treatment with SST-0225 or placebo for a 48 hour period. Subjects will be housed in the clinic for the first 24 hours of dosing and sent home for the second 24 hour dosing period. Arm pain/soreness will be assessed throughout the study using an 11-point (0-10) Numeric Rating Scale (NRS).

Approximately 150 subjects will be randomized in a 1:1 ratio to SST-0225 or placebo at up to three study centers in the US. Subject participation will be between 12 and 26 days depending on the length of the initial screening period. Once a subject is randomized the duration of participation will be 10 days. The expected duration of the study is approximately six months depending on enrollment. The sample size may be increased to a maximum of 250 based on the results of the planned interim analysis described in Section 15.2 of the protocol.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
SST-0225	SST-0225	Subjects will be treated with IP for 48 hours. While on-site, subjects will apply the first dose of IP at 0 hours, the second dose at 2 hours, and all subsequent doses every 5 (±1) hours, up to a maximum of 6 doses in 24 hours. After subjects complete their 24 hour post first dose NRS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the remaining 24 hours. While off-site subjects will dose every 5 (±1) hours, not to exceed 6 doses in 24 hours.
Placebo	Placebo	Subjects will be treated with IP for 48 hours. While on-site, subjects will apply the first dose of IP at 0 hours, the second dose at 2 hours, and all subsequent doses every 5 (±1) hours, up to a maximum of 6 doses in 24 hours. After subjects complete their 24 hour post first dose NRS pain/soreness on movement assessment, they will be released from the clinic and will continue outpatient treatment for the remaining 24 hours. While off-site subjects will dose every 5 (±1) hours, not to exceed 6 doses in 24 hours.

Primary Outcome Measures

Name	Time	Method
SPID24 (calculated by summing the time weighted NRS 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 NRS 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 NRS pain/soreness on movement assessment differences from baseline (pre-dose on Day 1) to 24 hours (using actual reported NRS assessment times) post first dose of IP on Day 1.

Secondary Outcome Measures

Name	Time	Method

Locations (3): Site #202
🇺🇸
Springfield, Missouri, United States
Site #203
🇺🇸
Hollywood, Florida, United States
Site #201
🇺🇸
South Miami, Florida, United States