ONO-4474-03
- Conditions
- Knee Osteoarthritis
- Registration Number
- JPRN-jRCT2080223824
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 124
1. Healthy Japanese adult male subject
2. BMI (at the time of screening): 18.5 kg/m2 or more, less than 25.0 kg/m2
Age : 20 to 45 years
Sex : male
1. Japanese osteoarthritis (OA) patients
2. BMI (at the time of screening): 18.5 kg/m2 or more, less than 39.0 kg/m2
3. Patients with knee symptoms in >=6 months prior to the start of screening period and were diagnosed with OA already at the time of >=6 months prior to the start of screening period
4. Patients with knee pain caused by OA for >=4 days a week in >=3 months prior to the start of screening period
5. Patients who meet the criteria of OA (Clinical) defined in the American College of Rheumatology Criteria (ACR) at the time of screening.
6. Patients with Kellgren-Lawrence (KL) Grade 2 to 4 according to a knee finding of X-ray photograph at the time of screening
7. Patients with insufficient analgesic effects of same NSAIDs which are continuously used with consistent dose and administration in >=14days prior to the start of screening period.
Age : 40 to 75 years
Sex : male and female
1. Subjects who have been on a treatment for diseases such as respiratory, cardiovascular, central nerve system, digestive system, hepatic, renal, hematopoietic or endocrine function diseases, or subjects with a history of these diseases
2. Subjects with a history of serious allergy to drugs or food
3. Subjects with a history of drug dependence or alcohol dependence
1. Patients with secondary osteoarthritis
2. Patients who have received an artificial joint replacement or are planned to receive an artificial joint replacement during the study period on the diseased knee part of assessment leg
3. Patients with a past history or concurrent diseases of articular diseases accompanied with other pain than osteoarthritis
4. Patients with a past history or concurrent diseases of clinically significant nervous diseases
5. Patients with a past history or concurrent diseases of psychiatric diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <Phase 1 part><br>Safety, tolerability and pharmacokinetics<br><br><Phase 2 part><br>1. Safety, tolerability and pharmacokinetics<br>2. Average knee pain (VAS24) which the subject has felt during walking in the past 24 hours
- Secondary Outcome Measures
Name Time Method <Phase 2 part><br>1. Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)<br>2. Patient Global Assessment (PGA)<br>3. Usage amount of rescue treatments