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NCT04484428 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
A Phase 2 study, sponsored by Kowa Research Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 126
- Enrollment target
NCT04484428: Clinical Trial Phase 2 study, sponsored by Kowa Research Institute.
NCT04484428 is a Phase 2 study that was terminated before completion, run by Kowa Research Institute. The registered enrollment target is 126 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04484428, a Phase 2 study, was terminated before completion, sponsored by Kowa Research Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 126 participants
- Enrollment target
Study Summary
The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.
Primary Outcome
* Pain Intensity (PI) was assessed for study leg while standing using a patient rated 0-100 point scale where 0 = 'no Pain' and 100 = 'worst possible pain. Pain Intensity Differences (PID) was the difference between PI at time (i) minus PI at time (t+1). The Sum of Pain Intensity Difference (SPID) was calculated as a time-weighted Sum of PID scores over a number of hours. * Sum of pain intensity differences over 24 hours after initiating treatment (SPID24). SPID24 derived from pain scores assess
Interventions
- DRUG Menthol
- DRUG K-285
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2020-08-15 |
| Est. Completion | 2021-03-19 |
| Phase | Phase 2 |
Why NCT04484428 stopped before completion
NCT04484428 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Menthol is the first listed.
NCT04484428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04484428 about?
NCT04484428 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity". The purpose of this study to evaluate the efficacy and safety of K-285 compared with menthol gel for the treatment of delayed onset muscle soreness (DOMS) in the lower extremity.
What is the current status of trial NCT04484428?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 126 participants. The study started on 2020-08-15. Estimated completion is 2021-03-19.
What interventions are being tested in trial NCT04484428?
The interventions under investigation include: Menthol (DRUG), K-285 (DRUG).
Who is sponsoring clinical trial NCT04484428?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04484428's enrollment target sits among peer trials
126 556th of 2000 higher than 1,443 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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