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Determining the Optimal Dose of AD-211 in Patients With Osteoarthritis of the Knee

A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Determine the Optimal Dose of AD-211 in Patients With Osteoarthritis of the Knee

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07550231
Enrollment
200
Registered
2026-04-24
Start date
2026-06-01
Completion date
2027-03-01
Last updated
2026-04-24

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

Conditions

Osteoarthritis of the Knees

Brief summary

The purpose of this study is to determine the optimal dose of AD-211 in patients with osteoarthritis of the knee.

Detailed description

Osteoarthritis of the knee

Interventions

DRUGAD-211-L

Per oral, 1 tablet twice daily during the treatment period.

DRUGAD-211-M

Per oral, 1 tablet twice daily during the treatment period.

DRUGAD-211-H

Per oral, 1 tablet twice daily during the treatment period.

DRUGAD-2113

Per oral, 1 tablet twice daily during the treatment period.

DRUGPlacebo to AD-211-L/M

Per oral, 1 tablet twice daily during the treatment period.

DRUGPlacebo to AD-211-H

Per oral, 1 tablet twice daily during the treatment period.

DRUGPlacebo to AD-2113

Per oral, 1 tablet twice daily during the treatment period.

Sponsors

Addpharma Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Signed informed consent * Patients with osteoarthritis of the Knee * Other inclusions applied

Exclusion criteria

* Patients with secondary osteoarthritis of the knee * Other exclusions applied

Design outcomes

Primary

MeasureTime frame
Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target kneeBaseline to Week13

Contacts

CONTACTHyeji Lee
hjlee@addpharma.co.kr+82318915604
PRINCIPAL_INVESTIGATORJung Yoon Choi

Daegu Catholic University Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 25, 2026