Dosing Interval Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness

NCT02339129 | Completed Phase 2

• 1 other identifier: SST0225-US-111-001A
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Delayed Onset Muscle Soreness

Outcome Measures

Primary Outcomes (1)

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

  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.

  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 upon request (PRN), 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 VAS 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 upon request (PRN), 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 VAS 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.

Placebo

Eligibility Criteria

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

Healthy male and female subjects between 16 and 65 years of age.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Strategic Science & Technologies, LLC: lead

Study Sites (2)

Site #201

South Miami, Florida, 33143, United States

Location

Site #202

Springfield, Missouri, 65802, United States

Location

Study Officials

• Howard I Schwartz, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 12, 2015
• First Posted: January 15, 2015
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

US (2)