Randomized, Double-Blind Study of AK1830 in Patients with Pain due to Osteoarthritis of the knee.
Phase 2
- Conditions
- Pain due to osteoarthritis
- Registration Number
- JPRN-jRCT2031230469
- Lead Sponsor
- Kudo Katsuyasu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Male or female aged 40 to 85 years at the time of informed consent.
-Patient meets American College of Rheumatology Criteria (ACR) for Osteoarthritis of the knee
-Patient who fully understands the contents of the study and is competent to give consent.
Exclusion Criteria
-Patient has renal, hepatic, cardiac, pancreatic, or metabolic diseases or hematologic abnormality.
-Patient is on a current treatment for malignancy or has a history of malignancy within the past 5 years.
-Patient who are pregnant or may be pregnant, who wants to be pregnant during the trial period, patients who are nursing. Patient who cannot agree on proper contraception in the patient or the patient's female partner is a pregnant woman.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change from baseline on the numerical rating scale (NRS) for pain
- Secondary Outcome Measures
Name Time Method