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

NCT02597634 | Completed Phase 3

• 1 other identifier: SST0225-013
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 3

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.

Conditions

Delayed Onset Muscle Soreness, DOMS

Outcome Measures

Primary Outcomes (1)

• SPID24 (calculated by summing the time weighted NRS pain/soreness on movement assessment differences from baseline)

  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.

  First 24 hours after first dose

Study Arms (2)

SST-0225

EXPERIMENTAL

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.

Drug: SST-0225

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

SST-0225 DRUG

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.

Also known as: Topical Ibuprofen Cream

SST-0225

Placebo DRUG

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.

Also known as: Placebo Cream

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 16-65, inclusive
• 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
• Female subjects must agree to use medically acceptable contraceptive methods from the Screening Visit (unless otherwise stated) through end of study (EOS).
• Subjects must be able to speak, read, and comprehend English or Spanish, and complete required measurements as outlined in the protocol
• 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
• Subjects must agree to refrain from the use of restricted therapies during the screening period and until the completion of the dosing period

You may not qualify if:

• Subjects who have had an injury to the non-dominant arm such as adhesive capsulitis, bursitis, rotator cuff syndrome, within the six months prior to the Screening Visit
• Subjects with medial or lateral epicondylitis (tennis elbow) of the non-dominant arm
• Subjects who have an open wound, skin irritation, or infection on the non-dominant arm in the area to be treated
• Subjects who have engaged in any upper body resistance training in the six months prior to the Screening Visit
• Subjects who are actively engaged in manual or physical labor jobs (i.e. brick layer, construction worker, carpenter, house painter)
• Subjects who should not participate in strenuous exercise for medical reasons
• Subjects who have abnormal laboratory parameters at the Screening Visit that, in the opinion of the Investigator, could confound interpretation of the study results
• Subjects with an abnormal physical exam that, in the opinion of the Investigator, would interfere with study participation
• Subjects who have received oral or injectable systemic corticosteroids within three months prior to the Screening Visit
• Subjects with osteoarthritis of the hands, fingers, elbows, or shoulders
• Subjects with chronic pain
• Subjects with an allergy or a history of allergy or intolerance to aspirin, NSAIDs, acetaminophen or any of the excipients in the IP (L-arginine hydrochloride, glyceryl stearate, cetyl alcohol, squalane, xanthan gum, isopropyl myristate, oleic acid, propylene glycol, polysorbate 20, methyl paraben, phenoxyethanol, propyl paraben, dimethicone)
• Subjects with current viral or bacterial infections
• Subjects with certain medical conditions, including:
• Peptic ulcer disease

Sponsors & Collaborators

• Strategic Science & Technologies, LLC: lead

Study Sites (3)

Site #203

Hollywood, Florida, 33024, United States

Location

Site #201

South Miami, Florida, 33143, United States

Location

Site #202

Springfield, Missouri, 65802, United States

Location

Study Officials

• Thomas Wade, MD

  Site #201

  PRINCIPAL INVESTIGATOR

• David Seiden, MD

  Site #203

  PRINCIPAL INVESTIGATOR

• Kayce Morton, DO

  Site #202

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2015
• First Posted: November 5, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Locations

US (3)