Dosing Interval Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness
Condition: Delayed Onset Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.

      As part of the screening process, in the evening of Day -2, eligible subjects will undergo an
      exercise regimen designed to induce DOMS in the elbow flexor of the non-dominant arm (see
      Section 11). 36 (±2) hours following the exercise regimen, subjects will return to the clinic
      and be evaluated for eligibility into the active treatment phase of the study. Eligible
      subjects who experience a sufficient level of pain 36 (± 2) hours after exercise will be
      randomized to receive either SST-0225 or placebo.

      For the first 24 hour dosing period, the subject will remain in the clinic (on-site).
      Subjects will apply the first dose of Investigational Product (IP) at randomization (0 hours)
      and a second dose upon request (PRN or as needed). All subsequent doses will be applied every
      5 (±1) hours. The total number of doses shall not exceed 6 in this first 24 hour period.
      Subjects will also not be allowed to take any rescue medication during the first 24 hour
      dosing period.

      Subjects will complete the Visual Analog Scale (VAS) pain/soreness on movement assessments at
      the following time points while on-site the first 24 hours: 0 (prior to first dose of IP), 1,
      2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 16, and 24 hours post first dose of IP and
      immediately prior to the second dose of IP. All assessments must be completed unless the
      subject is asleep. Subjects will be restricted to a maximum of 8 hours of sleep in order to
      limit the number of missing VAS pain/soreness on movement assessments due to sleep.
      Immediately upon wakening on Day 2, subjects will be instructed to apply a dose of IP unless
      it has been less than 5 (±1) hours since their last dose of IP.

      After subjects complete their 24 hour VAS pain/soreness on movement assessment, they will be
      released from the clinic and will continue outpatient treatment for the second 24 hour dosing
      period.

      During the second 24 hour dosing period (24-48 hours post first dose of IP), the subject will
      be away from the clinic (off-site) and will apply the IP every 5 (±1) hours. The total number
      of doses shall not exceed 6 doses in this second 24 hour period. Rescue medication will be
      made available to subjects during this second 24 hour period. During this second 24 hour
      period, subjects will complete the VAS pain/soreness on movement assessment prior to each IP
      dose and at 1 hour post each dose of IP.

      Refer to the Schedule of Evaluations in Appendix A (on-site evaluations) and Appendix B
      (off-site evaluations) for details regarding the timing of study procedures.
    

Intervention name(s): SST-0225; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): Topical Ibuprofen Cream
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment