Osteoarthritis, Knee
Conditions
Brief summary
Prospective, multicenter, phase IV, open, randomized, parallel, controlled, in which 288 (two hundred and eighty-eight) participants of both sexes, aged between 40 and 75 years will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
Detailed description
This study evaluate the efficacy and safety of Dry Extract of Curcuma Longa complexed with phosphatidilcholine (Motore®) Compared to Ibuprofen (Alivium® ) in the treatment of adults with knee osteoarthritis. The study population will consist in participants of both sexes, aged between 40 and 80 years old with a clinical diagnosis of knee osteoarthritis (tibiofemoral joint) based on clinical and radiological criteria (Grades 2 and 3 Kellgren and Lawrence) and who had osteoarthritis symptoms in the last six (06) months preceding the start of the study. They will be randomly allocated to one of two treatment groups , and treatment group 01 will be the dried extract of Curcuma longa complexed with phosphatidylcholine (Motore®), and treatment group 02 will ibuprofen (Alivium®).
Interventions
DRUGMotore
250 mg
DRUGAlivium
600 mg
Sponsors
Ache Laboratorios Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participants of both sexes; * Age greater than or equal to 40 years and less than or equal to 75 years; * Clinical diagnosis of osteoarthritis of the knee (tibiofemoral joint) based on clinical and radiological criteria (Grade 2 and 3 Kellgren and Lawrence) as specified below: * Pain on movement in the affected knee on most days of the last month, with at least partial relief at rest; * Presence of osteophytes of at least 1 mm in radiological imaging, a report issued by a qualified professional from the center; * Symptoms of osteoarthritis in the last 06 months preceding the start of the study; * Visual Analogue Scale with 40mm or greater value (considering the data obtained at the randomization visit); * Ability to understand and consent to participate in this clinical study, manifested by signing the Informed Consent Form (ICF).
Exclusion criteria
* Any finding of clinical observation (clinical and physical examination) or laboratory finding that is interpreted by the researcher as a medical risk to participation in the clinical trial; * Any finding of ECG examination the investigator physician considers risk as to the research participant about their participation in the clinical trial; * Known hypersensitivity to the components of the medications used during the study; * Women in pregnancy or nursing period; * in premenopausal women who do not agree to use acceptable contraceptive methods (oral contraceptives, injectable contraceptives, hormonal implants, barrier methods, abstinence, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy); * concomitant arthropathy that may confuse or interfere with pain assessment or efficacy, including: inflammatory arthropathy (rheumatoid arthritis, systemic lupus erythematosus, spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatic), gouty arthritis, acute episodes of monoarthritis compatible with pseudogout, Paget's disease with involvement of the joint study, history of septic arthritis, avascular necrosis or intra-articular joint studied, Wilson's disease, hemochromatosis, alkaptonuria, primary osteochondromatosis fracture; * Infectious Arthritis as gonococcal and syphilitic; * History of significant collateral ligament injury, or anterior cruciate, or the meniscus of the joint study, requiring surgery or immobilization for more than three weeks (minor ligament injuries, six months prior to the study, are not
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in the pain domain score of the WOMAC questionnaire | After 42 (forty two) days of treatment | The primary efficacy endpoint will be the reduction in the pain domain score of the WOMAC questionnaire after 42 (forty two) days of treatment |
Countries
Brazil
Outcome results
None listed