Health TrialsbyHealthPanel

The Safety and Pharmacokinetics of ASKC200 in Osteoarthritic Knee Pain

ConditionsOsteoarthritis, KneePain
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age40-75
SponsorJiangsu Aosaikang Pharmaceutical Co., Ltd.

About this trial

This is a multi-center, randomized, double-blind clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASKC200 in subjects with OA of the knees and determine the phase II recommended dose. Assigned doses will be applied for 60 minutes on each of four consecutive days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Sign informed consent prior to any inspection and evaluation, and understand and follow test requirements;

Age 40-75 years old (including boundary value) at the time of signing the informed consent, gender is not limited;

Primary knee osteoarthritis was confirmed by clinical and imaging examination;

Knee osteoarthritis pain history ≥6 months;

Disqualifiers

Secondary arthritis caused by other causes;

The study knee has other knee pathologic findings confirmed by clinical evaluation or imaging

There are other conditions that can cause study knee pain or other physical pain;

Other medications for osteoarthritis were used within 1 week prior to the first dose;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5% ASKC200

    Drug

    5% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.

  • 1% ASKC200

    Drug

    1% ASKC200 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of1% for this study.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: 5% ASKC200Experimental treatment 1 intervention
Group B: 1% ASKC200Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety:Incidence of adverse events（AEs）

All adverse medical events occurring after the subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily have a causal relationship with the investigational drug.

Time frame
34 days

Secondary outcomes

1

Efficacy:Change in the NRS score of weekly average of average daily pain intensity(WAADPI) 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.

Time frame
Day 19, Day 34
2

Efficacy:Remission ratio of study knee according to NRS score

The average amount of pain as reported by the subject using a 0 - 10 numerical rating scale (NRS). Higher scores indicate more pain.

Time frame
Day 19, Day 34
3

Efficacy:Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score From Baseline

The WOMAC Index is a questionnaire used to assess health status and health outcomes in KOA. The questionnaire contains 24 questions（0-10） on pain, stiffness and physiology, will ask participants to complete the WOMAC questionnaire considering their symptoms in the past 48 hours.Higher scores indicate more pain.

Time frame
Day 19, Day 34
4

Efficacy:Change in patients clinical general impression (PCGI-C)

The change in patients clinical general impression as reported by the subject using a 0 - 7 scale (PCGI-C).Higher scores indicate worse state of pain.

Time frame
Day 19, Day 34

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: