Osteoarthritis (OA) of the KneePhase 2ASKC200NCT07742852

ASKC200 for Knee Osteoarthritis Pain

A Phase 2 study testing 5% ASKC200, 1% Diclofenac Diethylamine Emulgel and 1% ASKC200 in people with Osteoarthritis (OA) of the Knee and Pain, run by Jiangsu Aosaikang Pharmaceutical Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 80 years
Conditions the study is for: Osteoarthritis (OA) of the Knee, Pain
What is being tested?: 5% ASKC200, 1% Diclofenac Diethylamine Emulgel and 1% ASKC200
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 175 participants
Where: 1 siteChina
Study dates: 12 Sep 2025to 30 Sep 2026
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects must meet all of the following criteria:
Provide signed informed consent before undergoing any examinations or assessments, and understand and comply with the study requirements;
Aged 40 to 80 years (inclusive) at the time of signing the informed consent, male or female;
Diagnosed with primary knee osteoarthritis based on clinical and radiological examinations;
History of knee osteoarthritis pain lasting ≥ 6 months;
Within 3 months prior to dosing, X-ray of the tibiofemoral joint shows Kellgren-Lawrence Grade II or III in the target knee, with the contralateral knee grade not higher than the target side;

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Before the first dose, the weekly average of the daily mean pain NRS score in the target knee is ≥ 4 and < 8, and the weekly average of the daily mean pain NRS score in the contralateral knee is < 4;
Before the first dose, the WOMAC pain scale score for the target knee is ≥ 20, and the WOMAC pain scale score for the contralateral knee is < 20;
Willing to discontinue the use of non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and other analgesics, and to use only study-provided acetaminophen as rescue medication for knee osteoarthritis pain during the study period;
Body Mass Index (BMI) ≤ 40.0 kg/m²;
Male and female subjects of childbearing potential agree to voluntarily adopt effective contraceptive measures and have no plans for pregnancy, egg donation, or sperm donation from the screening period through 3 months after the last dose. Female subjects of childbearing potential must have a negative pregnancy test before the first use of the study drug.

Who cannot join

Subjects will be excluded from the study if they meet any of the following criteria:
Secondary arthritis due to other causes (e.g., psoriasis, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, etc.);
The target knee has other conditions that may affect the function and pain assessment of the target knee (e.g., fractures, osteonecrosis, and chondrocalcinosis within 6 months prior to screening, etc.);
Presence of other diseases causing pain in the target knee (e.g., hip pain, lumbar spinal stenosis, intermittent claudication, etc.) or pain in other areas that, in the investigator's judgment, may affect the assessment of knee osteoarthritis pain;
Use of other medications for osteoarthritis within 1 week prior to the first dose, such as NSAIDs (except aspirin ≤ 325 mg/day for cardiac prophylaxis), analgesics (except rescue acetaminophen used continuously for ≤ 3 days), symptomatic slow-acting drugs for osteoarthritis (diacerein, glucosamine, chondroitin sulfate, etc.), anxiolytics (doxepin, amitriptyline, pregabalin, etc.), or traditional Chinese medicines (containing active ingredients such as artificial tiger bone powder, Psammosilene tunicoides, etc.), whether oral or topical;
The target knee has pathological joint effusion requiring aspiration or has surgical indications;

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Presence of chronic pain in other body parts requiring long-term oral analgesic therapy, or need for concomitant systemic glucocorticoid therapy from 4 weeks prior to the first dose through the study period;
Open knee injury or other knee surgeries (e.g., arthroscopy, arthroscopic debridement, knee replacement, etc.) on the target knee within 6 months prior to the first dose;
Undergone any major surgical procedure within 3 months prior to the first dose;
Received intra-articular injection therapy (e.g., corticosteroids or sodium hyaluronate, etc.) in the target knee within 3 months prior to the first dose;
Received treatment with other investigational drugs or devices within 4 weeks prior to the first dose;
Received physical therapy (e.g., electrotherapy, etc.) for knee osteoarthritis in the target knee within 3 months prior to the first dose;
Patients who are unable to ambulate independently and require assistive devices for more than 50% of ambulation time within 4 weeks prior to the first dose;
Applied any capsaicin-containing products or NSAIDs to the skin of the target knee within 2 weeks prior to the first dose;
History of allergy, contraindication, or intolerance to any component of the investigational product ASKC200 liniment, the comparator diclofenac diethylamine emulgel, or the rescue medication acetaminophen, or to any other NSAIDs;
Presence of open wounds, skin erythema or edema, skin infection, or any other skin lesions on the target knee prior to the first dose that, in the investigator's opinion, may affect subject safety or absorption of the study drug;
Instability of the target knee, such as cruciate ligament tear, ligamentous laxity, or significant valgus/varus deformity;
History of gastrointestinal bleeding within 6 months prior to screening;
Subjects planning to undergo surgery during the study period (including but not limited to general surgery, orthopedic surgery, gynecological/obstetric surgery, etc.);
In the investigator's judgment, subjects have any clinically significant unstable cardiovascular, cerebrovascular, respiratory, neurological, immunological, hematological, hepatic, renal, or endocrine systemic disease that remains uncontrolled despite standard treatment;
Abnormal liver function tests (alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, total bilirubin ≥ 1.5 × ULN);
Abnormal renal function tests (creatinine ≥ 1.5 × ULN);
Clinically significant abnormalities on 12-lead ECG that, in the investigator's judgment, preclude participation, including but not limited to prolonged QTcF interval (defined as > 450 ms in males or > 470 ms in females), second-degree or third-degree atrioventricular block;
Subjects with uncontrolled hypertension without medication, or hypertension that remains uncontrolled despite medication (defined as systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg);
History of malignancy within 5 years (excluding successfully treated non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma and/or cervical carcinoma in situ);
History of alcohol or drug dependence within 12 months prior to the first dose;
Psychiatric disorders that may affect the subject's ability to comply with study procedures or complete the study (including but not limited to a history of mania, bipolar disorder, schizophrenia, or schizoaffective disorder);
Pregnant or breastfeeding women;
Subjects deemed by the investigator to have poor compliance or other reasons that make them unsuitable for participation in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Hospital
Beijing

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Active Drug/Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of ASKC200 in Patients With Knee Osteoarthritis Pain

Conditions: Osteoarthritis (OA) of the Knee, Pain
Being tested: 5% ASKC200, 1% Diclofenac Diethylamine Emulgel, Placebo, 1% ASKC200
Medical subject headings: Osteoarthritis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

5% ASKC200Drug
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.
1% Diclofenac Diethylamine EmulgelDrug
Day 5-18；Four times daily
PlaceboDrug
ASKC200 Placebo or Diclofenac Diethylamine Placebo
1% ASKC200Drug
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.

Study groups in NCT07742852
Study group	Role	What they receive
5% ASKC200	Experimental	Not described Receives: Drug: 5% ASKC200; Drug: Placebo
1% Diclofenac Diethylamine Emulgel	Active comparator	Not described Receives: Drug: 1% Diclofenac Diethylamine Emulgel; Drug: Placebo
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
1% ASKC200	Experimental	Not described Receives: Drug: Placebo; Drug: 1% ASKC200

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in WAADPI (NRS) of the target knee from baseline
The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.
Measured: Day 34

Secondary outcomes (4)

Change in WAADPI (NRS) of the target knee from baseline
The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.
Measured: Day 19, Day 64，Day 94
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
The WOMAC Index is a questionnaire used to assess health status and health outcomes in KOA. The questionnaire contains 24 questions on pain, stiffness and physiology, will ask participants to complete the WOMAC questionnaire considering their symptoms in the past 48 hours.
Measured: Day 19，Day 34，Day 64，Day 94
Change in patient's clinical general impression (PGIC)
The change in patient\'s clinical general impression as reported by the subject using a 0 - 7 scale (PGIC).
Measured: Day 19，Day 34 ，Day 64，Day 94
Days of first-aid medicine administration
Subjects will record their administration of first-aid medicine.
Measured: 94days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 202530 Sep 2026

First posted3 Aug 2026
Study start12 Sep 2025
Primary completion28 Apr 2026
Study completion30 Sep 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Osteoarthritis (OA) of the KneeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 175 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07742852
Sponsor's protocol ID: ASKC200-LC-201
Acronym: ASKC200
Status last verified: Jul 2026
First submitted: 26 Jul 2026
Last updated: 3 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
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Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
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RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
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The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA.
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All Osteoarthritis (OA) of the Knee trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Active Drug/Placebo-Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of ASKC200 in Patients With Knee Osteoarthritis Pain
ClinicalTrials.gov ID: NCT07742852
Acronym / sponsor ID: ASKC200 / ASKC200-LC-201
Conditions: Osteoarthritis (OA) of the Knee, Pain
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 175 participants (actual)
Lead sponsor: Jiangsu Aosaikang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Sep 2025 (actual)
Primary completion: 28 Apr 2026 (actual)
Study completion: 30 Sep 2026 (estimated)
First posted: 3 Aug 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
5% ASKC200	Experimental	Drug: 5% ASKC200, Drug: Placebo
1% Diclofenac Diethylamine Emulgel	Active comparator	Drug: 1% Diclofenac Diethylamine Emulgel, Drug: Placebo
Placebo	Placebo comparator	Drug: Placebo
1% ASKC200	Experimental	Drug: Placebo, Drug: 1% ASKC200

Who may qualify

Ages: 40 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Provide signed informed consent before undergoing any examinations or assessments, and understand and comply with the study requirements;
Aged 40 to 80 years (inclusive) at the time of signing the informed consent, male or female;
Diagnosed with primary knee osteoarthritis based on clinical and radiological examinations;
History of knee osteoarthritis pain lasting ≥ 6 months;
Within 3 months prior to dosing, X-ray of the tibiofemoral joint shows Kellgren-Lawrence Grade II or III in the target knee, with the contralateral knee grade not higher than the target side;

Key exclusion criteria (29 listed)

Secondary arthritis due to other causes (e.g., psoriasis, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, etc.);
The target knee has other conditions that may affect the function and pain assessment of the target knee (e.g., fractures, osteonecrosis, and chondrocalcinosis within 6 months prior to screening, etc.);
Presence of other diseases causing pain in the target knee (e.g., hip pain, lumbar spinal stenosis, intermittent claudication, etc.) or pain in other areas that, in the investigator's judgment, may affect the assessment of knee osteoarthritis pain;
Use of other medications for osteoarthritis within 1 week prior to the first dose, such as NSAIDs (except aspirin ≤ 325 mg/day for cardiac prophylaxis), analgesics (except rescue acetaminophen used continuously for ≤ 3 days), symptomatic slow-acting drugs for osteoarthritis (diacerein, glucosamine, chondroitin sulfate, etc.), anxiolytics (doxepin, amitriptyline, pregabalin, etc.), or traditional Chinese medicines (containing active ingredients such as artificial tiger bone powder, Psammosilene tunicoides, etc.), whether oral or topical;
The target knee has pathological joint effusion requiring aspiration or has surgical indications;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
5% ASKC200A 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	5% ASKC200
1% Diclofenac Diethylamine EmulgelDay 5-18；Four times daily	Drug	1% Diclofenac Diethylamine Emulgel
PlaceboASKC200 Placebo or Diclofenac Diethylamine Placebo	Drug	1% ASKC200, 1% Diclofenac Diethylamine Emulgel, 5% ASKC200, Placebo
1% ASKC200A 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% ASKC200

Primary outcome

Change in WAADPI (NRS) of the target knee from baseline
Time frame: Day 34
The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.

4 secondary outcomes

Change in WAADPI (NRS) of the target knee from baseline
Time frame: Day 19, Day 64，Day 94
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score
Time frame: Day 19，Day 34，Day 64，Day 94
Change in patient's clinical general impression (PGIC)
Time frame: Day 19，Day 34 ，Day 64，Day 94
Days of first-aid medicine administration
Time frame: 94days

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Individual participant dataSharing planned: No

Related trials for Osteoarthritis (OA) of the Knee

Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Not yet recruiting
The Effect of Theory-driven Physiotherapy on Physical Activity in Knee OA.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in WAADPI (NRS) of the target knee from baseline (time frame: Day 34). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07742852.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.