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NCT02597634: DOMS
A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy, and Safety of SST-0225, a Topical Ibuprofen Cream, in the Treatment of Delayed Onset Muscle Soreness (DOMS)
Phase 3 trial testing SST-0225 in Delayed Onset Muscle Soreness, DOMS in 156 participants. Completed in 1 October 2016.
1 October 2016
Quick facts
| Lead sponsor | Strategic Science & Technologies, LLC |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 156 |
| Start date | 1 November 2015 |
| Primary completion | 1 October 2016 |
| Estimated completion | 1 October 2016 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- SST-0225 — full drug profile →
- Placebo
Conditions studied
- Delayed Onset Muscle Soreness, DOMS — all drugs for Delayed Onset Muscle Soreness, DOMS →
Sponsor
Strategic Science & Technologies, LLC — full company profile →
Who can join
Adults 16 to 65, any sex, with Delayed Onset Muscle Soreness, DOMS. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
SPID24 (calculated by summing the time weighted NRS pain/soreness on movement assessment differences from baseline)
Time frame: 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 actu
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02597634
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Strategic Science & Technologies, LLC trials
Trials by the same sponsor.
- NCT04948151 — Multi-Center Study to Evaluate the Efficacy and Safety of Sildenafil Cream (3.6%) in Premenopausal Patients With Female · Phase 2 · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02597634 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Strategic Science & Technologies, LLC
- Last refreshed: 12 October 2016
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02597634.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing