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NCT02695381
A Randomized, Double-blind, Multiple-dose, Placebo-controlled Study to Evaluate the Efficacy and Safety of Etodolac-lidocaine Patch Applied Once Daily in Subjects Experiencing Acute Delayed Onset Muscle Soreness
Phase 3 trial testing Etodolac-lidocaine topical patch in Acute Delayed Onset Muscle Soreness (DOMS) in 100 participants. Completed in 1 September 2016.
1 August 2016
Quick facts
| Lead sponsor | MEDRx USA, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 March 2016 |
| Primary completion | 1 August 2016 |
| Estimated completion | 1 September 2016 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Etodolac-lidocaine topical patch — full drug profile →
- Placebo
Conditions studied
- Acute Delayed Onset Muscle Soreness (DOMS) — all drugs for Acute Delayed Onset Muscle Soreness (DOMS) →
Sponsor
MEDRx USA, Inc. — full company profile →
Who can join
Adults 18 to 35, any sex, with Acute 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.
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Sum of the time-weighted differences from baseline in pain intensity with movement (SPIDMove) over 0-24 hours post-T0 (SPIDMove 0-24 hours).
Time frame: 24 hours
Sponsor's own description
This study evaluate the efficacy and safety of Etodolac-lidocaine topical patch applied one time daily when compared with placebo in the treatment of acute Delayed Onset Muscle Soreness (DOMS) of the upper limbs.
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 NCT02695381
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 NCT02695381 (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 MEDRx USA, Inc.
- Last refreshed: 8 September 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/NCT02695381.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing