A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in … (NCT05337540) | Clinical Trial Compass
CompletedNot Applicable
A Study to Evaluate the Efficacy, Safety and Tolerability of EVI-01 Intra-Articular Injection in Osteoarthritis of the Knee
Brazil120 participantsStarted 2024-01-17
Plain-language summary
Objective: Identifying the dose of EVI-01 with the best clinical response, balancing the efficacy, safety, and tolerability of the investigational product.
Study design: Interventional, dose-finding, three arms, randomized (1:1:1), parallel assignment, double-blind, controlled by an active comparator.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients of both genders aged 18 years or older;
✓. Body Mass Index (BMI) \< 35 kg/m2;
✓. Diagnosis of primary knee osteoarthritis, Kellgren-Lawrence Grade 2 to 4, according to American College of Rheumatology (ACR) criteria and confirmed radiologically within the previous 12 months, for which an intraarticular treatment is indicated;
✓. Moderate to severe pain measured by VAS (0-100mm) and \>40mm in the knee to be treated, partially responsive to chronic doses of nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or weak opioids (codeine and tramadol);
✓. Ability to understand and provide signed consent through the Informed Consent Form (ICF).
Exclusion criteria
✕. History of hypersensitivity/allergy to hyaluronic acid (HA) or other excipients of the IP or product;
✕. Pregnant or breastfeeding women;
✕. Women at menace who do not agree to use acceptable contraceptive methods (oral contraceptive, injectable contraceptive, IUD, hormonal implant, barrier methods, sexual abstinence, hormone transdermal patch and tubal ligation); except those who are surgically sterile (bilateral oophorectomy or hysterectomy);
✕. Emotional problems or any situation that, at the Investigator's discretion, places the safety of subjects at risk;
✕. Application of visco-supplementation to the knee less than four months prior to randomization;
What they're measuring
1
Changes to the questionnaire WOMAC A (Western Ontario and McMaster Universities) Numeric 3.1
Timeframe: from baseline to 180 days after randomization
2
Comparison of treatment-related Adverse Events in the three groups
Timeframe: from baseline to 180 days after randomization