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Randomized, Double-Blind Study of AK1830 in Patients with Pain due to Osteoarthritis of the knee.

Randomized, Double-Blind Study of AK1830 in Patients with Pain due to Osteoarthritis of the knee.

Yoshitani Mai

ASAHI KASEI THERAPEUTICS CORPORATION

1-1-2 Yurakucho, Chiyoda-ku, Tokyo

ct-info@om.asahi-kasei.co.jp

Contact for Clinical Trial Information

ASAHI KASEI THERAPEUTICS CORPORATION

1-1-2 Yurakucho, Chiyoda-ku, Tokyo

+81-3-6699-3600

ct-info@om.asahi-kasei.co.jp

Complete

Jan. 15, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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.

Both

Pain due to osteoarthritis

-AK1830 (3 doses)
-Placebo
This study consists of 4 study arms (Placebo arm and AK1830 dose1~3 arms).

Mean change from baseline on the numerical rating scale (NRS) for pain

+81-3-5213-0028

Nov. 14, 2023

Yes

*Individual subject-level data will be provided in a secure access environment after review and approval by a review committee. *All data provided to outside investigators will be anonymized to respect patient privacy.

none