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Not yet recruiting NCT07550231

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

Phase II Interventional Osteoarthritis of the Knees

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AD-211-L, AD-211-M, AD-211-H, AD-2113.
Who it may be relevant to
Registry conditions: Osteoarthritis of the Knees. Basic parameters: 19 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug AD-211-L
    Per oral, 1 tablet twice daily during the treatment period.
  • Drug AD-211-M
    Per oral, 1 tablet twice daily during the treatment period.
  • Drug AD-211-H
    Per oral, 1 tablet twice daily during the treatment period.
  • Drug AD-2113
    Per oral, 1 tablet twice daily during the treatment period.
  • Drug Placebo to AD-211-L/M
    Per oral, 1 tablet twice daily during the treatment period.
  • Drug Placebo to AD-211-H
    Per oral, 1 tablet twice daily during the treatment period.
  • Drug Placebo to AD-2113
    Per oral, 1 tablet twice daily during the treatment period.

Primary outcome measures

  • Change from baseline in 100 mm Pain VAS score during activity over the past 24 hours in the target knee [Time frame: Baseline to Week13]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07550231 · AD-211P2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗