Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT05294432
Eligibility Criteria:
Inclusion Criteria:
* Given written Informed Consent to participate in the study
* Male or female ≥40 years of age
* Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening requiring the use of regular therapies.
* If bilateral OA exists, pain in the contralateral knee must be less than pain in the index knee as reported by patient
* Index knee pain on most days (\>15) over the last month
* Mean score of ≥4 and ≤9 on the 24-hr average pain score (0-10 NRS) using the average daily ratings at least 5 out of 7 days prior to Day 1(Baseline)
* Have been prescribed and scheduled to receive at least one corticosteroid (triamcinolone) injection to the affected knee
* Willingness and ability to comply with the study procedures and visit schedules and the ability to follow verbal and written instructions
Exclusion Criteria:
* Lack of signed Informed Consent Form
* Age less than 40 years old
* Have any contraindications to administration of corticosteroid medication by intra-articular injection
* Patients with diagnoses of fibromyalgia, chronic pain syndrome, or other concurrent medical or arthritic conditions which could interfere with the evaluation of the index knee
* Patients with diagnoses of rheumatoid arthritis, psoriatic arthritis, or any other form of inflammatory arthritis
* Planned/anticipated surgery in the affected area within 3 months during the study period.
* Previous intra-articular corticosteroid injection into the index joint within 3 months prior to Screening
* Concomitant treatment with corticosteroid or other injections into the index joint (e.g. prolotherapy) within 3 months during the study period
* Concomitant treatment with oral or topical (to the index knee) corticosteroids within 3 months during the study period (except inhaled, intranasal, or topical applied not to the index knee)
* Any other investigational drug/biologic applied to affected area within 3 months during the study period
* Diagnosis of dementia or other cognitive impairments that would preclude questionnaires completion
* Any clinically significant acute or chronic medical conditions that, in the judgment of Investigator, would preclude the use of corticosteroid injections or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study
* Participation in any other clinical study within 3 months prior to Screening and during the study period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05294432
Study Brief:
Protocol Section:
NCT05294432