NCT04484428

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

Terminated Phase 2 Results posted Last updated 27 December 2024

What this trial tests

Phase 2 trial testing K-285 in Acute Pain in 126 participants. Terminated before completion.

Timeline

15 August 2020

Primary endpoint
19 March 2021

19 March 2021

Quick facts

Lead sponsor	Kowa Research Institute, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	126
Start date	15 August 2020
Primary completion	19 March 2021
Estimated completion	19 March 2021
Sites	1 location across United States

Drugs / interventions tested

• K-285 — full drug profile →
• Menthol — full drug profile →

Conditions studied

• Acute Pain — all drugs for Acute Pain →

Sponsor

Kowa Research Institute, Inc. — full company profile →

Who can join

Adults 18 to 35, any sex, with Acute Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Sum of Pain Intensity Difference Between 0 to 24 Hours (SPID0-24) for Study Leg While Standing Primary · Baseline to 24 Hours

* 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 assessed over 24 hours on a 0 -100 point scale. SPID24 was computed using the trapezoidal rule, i.e. Σ \[T

Group	Value	95% CI
K-285	-488.0	± 58.54
Menthol Gel	-512.0	± 58.53

SPID0-24 at Rest for Study Leg Secondary · Baseline to 24 Hours

* Pain Intensity (PI) was assessed at rest for study leg 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 assessed over 24 hours on a 0 -100 point scale. SPID24 was computed using the trapezoidal rule, i.e. Σ \[T(i+1) -

Group	Value	95% CI
K-285	-358.3	± 54.42
Menthol Gel	-355.6	± 54.45

SPID0-12 While Standing for Study Leg Secondary · Baseline to 12 Hours

* Pain Intensity (PI) was assessed while standing for study leg 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 12 hours after initiating treatment (SPID12). SPID12 derived from pain scores assessed over 12 hours on a 0 -100 point scale. SPID12 was computed using the trapezoidal rule, i.e. Σ \[T

Group	Value	95% CI
K-285	-190.2	± 26.83
Menthol Gel	-209.2	± 26.83

SPID0-12 at Rest for Study Leg Secondary · Baseline to 12 Hours

* Pain Intensity (PI) was assessed at rest for study leg 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 12 hours after initiating treatment (SPID12). SPID12 derived from pain scores assessed over 12 hours on a 0 -100 point scale. SPID12 was computed using the trapezoidal rule, i.e. Σ \[T(i+1) -

Group	Value	95% CI
K-285	-131.5	± 25.28
Menthol Gel	-140.8	± 25.29

SPID0-48 While Standing for Study Leg Secondary · Baseline to 48 Hours

* Pain Intensity (PI) was assessed while standing for study leg 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 48 hours after initiating treatment (SPID48). SPID48 derived from pain scores assessed over 48 hours on a 0 -100 point scale. SPID48 was computed using the trapezoidal rule, i.e. Σ \[T

Group	Value	95% CI
K-285	-1229.9	± 123.15
Menthol Gel	-1221.1	± 123.14

SPID0-48 at Rest for Study Leg Secondary · Baseline to 48 Hours

* Pain Intensity (PI) was assessed at rest for study leg 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 48 hours after initiating treatment (SPID48). SPID48 derived from pain scores assessed over 48 hours on a 0 -100 point scale. SPID48 was computed using the trapezoidal rule, i.e. Σ \[T(i+1) -

Group	Value	95% CI
K-285	-959.4	± 114.80
Menthol Gel	-909.5	± 114.85

SPID0-72 While Standing for Study Leg Secondary · Baseline to 72 Hours

* Pain Intensity (PI) was assessed while standing for study leg 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 72 hours after initiating treatment (SPID72). SPID72 derived from pain scores assessed over 72 hours on a 0 -100 point scale. SPID72 was computed using the trapezoidal rule, i.e. Σ \[T

Group	Value	95% CI
K-285	-2154.1	± 184.65
Menthol Gel	-2160.8	± 184.64

SPID0-72 at Rest for Study Leg Secondary · Baseline to 72 Hours

* Pain Intensity (PI) was assessed at rest for study leg 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 72 hours after initiating treatment (SPID72). SPID72 derived from pain scores assessed over 72 hours on a 0 -100 point scale. SPID72 was computed using the trapezoidal rule, i.e. Σ \[T(i+1) -

Group	Value	95% CI
K-285	-1730.1	± 169.61
Menthol Gel	-1678.3	± 169.68

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 29 Days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

K-285

Serious: 0/63 (0%)

Deaths: 0/63

Menthol Gel

Serious: 0/63 (0%)

Deaths: 0/63

Other adverse events (2 terms — click to expand)

Reaction	System	K-285	Menthol Gel
Application site erythema	General disorders	—	—
Application site pruritus	General disorders	—	—

Data from ClinicalTrials.gov NCT04484428 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.