jRCT2031230469Active, not recruitingNot Applicable
Randomized, Double-Blind Study of AK1830 in Patients with Pain due to Osteoarthritis of the knee.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 400
- Primary Endpoint
- -
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized Controlled Trial
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment Purpose
- Masking
- Double Blind
Eligibility Criteria
- Ages
- 40age old over to 85age old under (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
-
Mean change from baseline on the numerical rating scale (NRS) for pain
Secondary Outcomes
No secondary outcomes reported
Investigators
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