Delayed Onset Muscle Soreness, DOMS
Conditions
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.
Interventions
DRUGSST-0225
SST-0225 is a cream formulation for topical application. Each 5.4 g dose is formulated to topically deliver 400 mg of ibuprofen. The cream contains sodium ibuprofen and various salts.
DRUGPlacebo
Placebo IP will be the same vehicle as SST-0225 vehicle without the active ingredient, ibuprofen. It will be matched in appearance, smell, consistency, and color to SST-0225 topical ibuprofen cream.
Sponsors
Strategic Science & Technologies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria The following inclusion criteria will be assessed from the Screening Visit up to the time of randomization: 1. Men and women age 16-65, inclusive 2. Subjects must be able to read, understand, sign, and date the informed consent/assent document indicating they (or a legally acceptable representative) have been informed of all pertinent aspects of the trial 3. Female subjects must agree to use medically acceptable contraceptive methods from the Screening Visit (unless otherwise stated) through end of study (EOS). 4. Subjects must be able to speak, read, and comprehend English or Spanish, and complete required measurements as outlined in the protocol 5. Subjects must agree to refrain from upper body resistance training and any unusual or excessive exercise during the screening period and for the duration of the study, including follow-up 6. Subjects must agree to refrain from the use of restricted therapies during the screening period and until the completion of the dosing period Key
Exclusion criteria
The following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed