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ASKC200 for Knee Osteoarthritis Pain

NCT07742852 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2026-08-03

No results posted yet for this study

Summary

This is a Phase II clinical trial designed to evaluate the efficacy and safety of ASKC200 Lotion in patients with knee osteoarthritis (KOA) pain. A total of 175 eligible patients will be randomly assigned to three groups at a 1:2:2:2 ratio: the experimental group1 (treated with 1% ASKC200 Lotion), the experimental group 2(treated with 5% ASKC200 Lotion), the active control group (treated with Diclofenac Diethylamine Emulgel), and the placebo group (treated with matching placebos).

Conditions

  • Osteoarthritis (OA) of the Knee
  • Pain

Interventions

DRUG

5% ASKC200

A single dose will be topically applied to study knees for 60 minutes on Visit 1 on Day 1, Day 2, Day 3, and Day 4.

DRUG

1% Diclofenac Diethylamine Emulgel

Day 5-18；Four times daily

DRUG

Placebo

ASKC200 Placebo or Diclofenac Diethylamine Placebo

DRUG

1% ASKC200

A single dose will be topically applied to study knees for 60 minutes on Visit 1 on Day 1, Day 2, Day 3, and Day 4.

Sponsors & Collaborators

  • Jiangsu Aosaikang Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-12
Primary Completion
2026-04-28
Completion
2026-09-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07742852 on ClinicalTrials.gov