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NCT02597634 · ClinicalTrials.gov registry record · Phase 3
Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness (DOMS)
A Phase 3 study of Delayed Onset Muscle Soreness (DOMS), sponsored by Strategic Science & Technologies.
- Completed
- Registry status
- Phase 3
- Development phase
- 156
- Enrollment target
- 3
- Study locations
NCT02597634: Completed Phase 3 study of Delayed Onset Muscle Soreness (DOMS), sponsored by Strategic Science & Technologies.
NCT02597634 is a Phase 3 study of Delayed Onset Muscle Soreness (DOMS) that has completed, run by Strategic Science & Technologies. The registered enrollment target is 156 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02597634, a Phase 3 study of Delayed Onset Muscle Soreness (DOMS), has completed, sponsored by Strategic Science & Technologies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 156 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SST-0225
Study Locations (3)
Florida
- Site #203 - Hollywood
- Site #201 - South Miami
Missouri
- Site #202 - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2015-11 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02597634 record still lists
NCT02597634 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Delayed Onset Muscle Soreness (DOMS) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02597634 reports a single indexed study location in Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT02597634 about?
NCT02597634 is a clinical study titled "Study of SST-0225 Topical Ibuprofen Cream in the Treatment of Delayed Onset Muscle Soreness (DOMS)". 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.
What is the current status of trial NCT02597634?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 156 participants. The study started on 2015-11. Estimated completion is 2016-10.
What conditions does trial NCT02597634 study?
This clinical trial studies the following conditions: Delayed Onset Muscle Soreness (DOMS).
What interventions are being tested in trial NCT02597634?
The interventions under investigation include: Placebo (DRUG), SST-0225 (DRUG).
Who is sponsoring clinical trial NCT02597634?
This trial is sponsored by Strategic Science & Technologies, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02597634 being conducted?
This trial has 3 study locations across Florida, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Delayed Onset Muscle Soreness (DOMS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02597634's enrollment target sits among peer trials
156 1506th of 2000 higher than 492 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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