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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.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031230469
Enrollment
400
Registered
2023-11-21
Start date
2024-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain due to osteoarthritis

Interventions

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

Sponsors

Yoshitani Mai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

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

Contacts

Public ContactClinical Trial Information Contact for

ASAHI KASEI THERAPEUTICS CORPORATION

ct-info@om.asahi-kasei.co.jp+81-3-6699-3600

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026