Multi-center Phase 2 Trial for Orally Administered M002 to Evaluate Evaluate Safety and Efficacy in Patients with Knee and Hip Osteoarthritis
- Conditions
- Diseases of the musculoskeletal system and connective tissue
- Registration Number
- KCT0008130
- Lead Sponsor
- Mecoxcuremed
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
1) Patients who voluntarily decided to participate and agreed in writing after hearing about the characteristics of this clinical trial and the clinical trial drug.
2) Those who meet all of the following criteria (Part A only)
(1) a man between 19 and 50 years of age
(2) Weight not less than 40 kg and not more than 90 kg; BMI not less than 18.5 and not more than 30 kg
(3) Those determined to be suitable for this clinical trial as a result of screening tests (physics,
Participation is possible if laboratory results, imaging, and electrocardiogram results are outside the normal range, but clear evidence of participation is provided at the discretion of the tester; participation is possible if AST, ALT are less than 1.25 times the normal range limit, and BUN, Cr are less than 1.5 times the normal range limit.
(4) A male test subject whose partner is likely to have childbearing (including women on hand) must agree to use the appropriate contraceptive methods during the clinical trial period and not donate sperm until one month after the trial period and the end of the trial
• It is one of the following: infertility surgery (such as vasectomy), hormonal contraception, intrauterine devices (such as copper loops), and hormonal intrauterine systems.
• Combining either parenteral hormone contraceptives or antiseptic with the barrier method
• Cervical caps or contraceptive diaphragm combined with male condoms
3) Those who meet all of the following criteria (Part B only)
(1) adult men and women aged 40 to under 80
(2) Less than 40 BMI
(3) Ambulance (ambulatory)
(4) A person who meets the following criteria for pain in either knee or hip joint that is subject to evaluation (index knee):
? pain lasting more than three months
? Pain visual acuity (VAS) > 40mm
(5) One or more of the following American College of Rheumatology (ACR) criteria (based on osteoarthritis of the knee or hip joint) are met.
osteoarthritis of the knee
? Kellgren-Lawrence grade 1 to 3 months of examination of knee joint x-ray (Kellgren-Lawrence grade 1 to 3) (However, even if osteoarthritis such as osteoarthritis is not clear on radiation, it is possible to recruit osteoarthritis matching findings (micro osteoarthritis) by knee ultrasound)
? One or more of the following three items:
? Age > 50 years old
? early stiffness <30 minutes
? ? (crepitus)Kellgren-Lawrence (K-L) grade 1~3
hip osteoarthritis
? If osteoarthritis consistent with osteoarthritis is observed by ultrasound even if osteoarthritis findings such as osteoarthritis are not clear on the hip x-ray examination performed within 3 months, it is possible to recruit
? Two or more of the following three items:
? ? ESR <20 mm/hour
? femur or acetabular osteoporosis in hip radiologic findings performed within 3 months
? Joint cavity stenosis (upper, axial, and/or inner) in radiation findings performed within 3 months
(6) Patients requiring medication for more than 8 weeks due to osteoarthritis symptoms
(7) A male test subject whose partner is likely to have childbearing (including women on hand) must agree to use the appropriate contraceptive methods during the clinical trial period and not donate sperm until one month after the trial period and the end of the trial
• It is one of the following: infertility surgery (such as vasectomy), hormonal contraception, intrauterine devices (such as copper loops), and hormonal intrauterine systems.
• Combining either parenteral hormone cont
Part A only
1) The following are clinically significant diseases determined by the tester: hepatometer, kidney, nervous system (central or peripheral), respiratory system, endocrine system (diabetes, hyperlipidemia, etc.), cardiovascular system (ceremonic heart failure, coronary artery disease, myocardial infarction, etc.), blood, tumor, urinary system, mental, musculoskeletal system, immune system (meris arthritis, systemic lupus, etc.).
? People with hemorrhagic diseases (digestive ulcers, intracranial bleeding, hemophilia, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, etc.)
? a liver disorder
? a kidney disorder
2) In vital signs measured in a sitting position after resting for more than 3 minutes, those who showed blood pressure included in either of systolic blood pressure 140 140 mmHg or 90 90 mmHg or diastolic blood pressure 95 95 mmHg or 50 50 mmHg.
3) When screening, electrocardiogram QTc>430 ms, PR interval>200 msec or QRS interval>120 msec, or other clinically significant electrocardiogram findings
4) A person who has symptoms of fever of 38°C or higher within one week of the date of administration of symptomatic infections or clinical trial drugs.
5) Bleeding of 400 ml or more within 8 weeks prior to administration of clinical trial drugs; A person who donated whole blood within 2 months prior to the first administration date or donated components within 1 month prior to the first administration date;
6) If urine drug screening tests are positive
7) A person who cannot drink continuously (over 21 units/week, 1 unit = 10 g of pure alcohol) or drink alcohol from 24 hours before hospitalization to discharge.
8) an alcohol test positive
9) Smokers with an average of more than 10 cigarettes a day over the last 3 months (but can be selected as subjects if they quit smoking 3 months before the date of the first dose) and positive in urine cotinine tests
10) Those who have consumed caffeine-containing foods (coffee, tea (green tea, etc.), carbonated drinks, coffee milk, nutritional tonic drinks, etc.) from 24 hours before hospitalization to discharge from the hospital, and those who cannot be prohibited from taking them.
11) Those who have taken prescription drugs or herbal medicines within two weeks before administration of clinical trial drugs and those who have taken general drugs or vitamin preparations within one week before administration of clinical trial drugs (but can participate in clinical trials if other conditions are reasonable at the discretion of the tester)
12) A person who participated in another clinical trial (including biological equivalence test) and administered a clinical trial drug within 6 months before the first administration of the clinical trial drug.
Part B only
1) An index knee or index hip joint falls under the following conditions:
(1) (1)Kellgren-Lawrence grade 4
(2) Secondary knee or hip osteoartritis
2) The following conditions correspond to levels at which pain may impair evaluation of the knee joint or hip joint (index knee) under evaluation:
(1) Other joint diseases include septic arthritis, inflammatory joint disease, gout, recurrent pseudogout, rheumatoid arthritis, Paget's disease, joint fracture, tissue melanosis, terminal giantosis, hemoglobinosis, Wilson's disease, genetic diseases (e.g., hyperkineticism), collagen genetic abnormalities, etc.
(2) Diseases such as pain-related lower extremity diseases, intervertebral disc herniation or spinal sten
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The amount of change compared to the baseline of the evaluated visual event scale before and after administration of the clinical trial drug (visit 4)
- Secondary Outcome Measures
Name Time Method Changes in visual event scale, WOMAC, pain NRS, etc. compared to baseline