Status:
COMPLETED
Efficacy and Safety of a Intra-articular Injection, ENKO1, in Patients With Symptomatic Knee Osteoarthritis.
Lead Sponsor:
OPKO Health, Inc.
Collaborating Sponsors:
Osteoarthritis Foundation International (OAFI)
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
Clinical trial with medical device, multicenter, single-blind (blind third party evaluation), randomized, comparative and in two paralell groups, to demonstrate the treatment according to usual clinic...
Eligibility Criteria
Inclusion
- Medial femorotibial compartment knee OA.
- Fulfilment of ACR criteria for knee OA (knee pain + grinding + stiffness in the morning \< 30 minutes).
- Patients with a clinical course of disease longer than 6 months.
- Global pain score greater than 60 mm on a 0-100 mm VAS on the knee under study.
- Grade II or III according to the Kellgren and Lawrence classification system for the knee under study (on a posteroanterior X-ray performed under weight-bearing and for 6 months before randomisation).
- Patients taking analgesics for at least 3 months before randomisation and whom are dissatisfied with their current therapy.
- Patients who have given their consent in writing to take part in the study.
- Woman of childbearing age must take a urine pregnancy test which must be negative at the randomisation visit and be currently using an effective contraceptive method for at least 2 menstrual cycles (oral contraceptives, intrauterine device, tubal ligation or other effective procedures).
Exclusion
- Isolated symptomatic patellofemoral osteoarthritis.
- Microcrystalline osteoarthritis.
- Prosthesis in knee under study.
- Joint lavage or arthroscopy or any surgery on the knee under study in the 6 months before randomisation.
- Paget's disease of bone, chondromatosis or villonodular sinovitis.
- Inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, spondyloarthropathy or connective tissue diseases).
- Haemochromatosis, ochronosis or haemophilia.
- History of diseases that the investigator considers likely to interfere with the functional disability assessment.
- Knee surgery planned during the study period.
- Other disease-related criteria:
- BMI greater than or equal to 30.
- Immunodeficiency or a serious or progressive disease (heart, lung, liver, kidney, haematological, neoplastic or infectious disease).
- Skin diseases or infections in the area of the injection site.
- Previous history of venous thromboembolism (including pulmonary embolism) or high risk of venous thromboembolism.
- Venous or lymphatic stasis of the leg under study.
- Severe acute or chronic disease that the investigator considers incompatible with the conduct of the study.
- Disease that the investigator considers likely to interfere with the study results or to expose the patient to an additional risk.
- Alcohol or drug abuse or dependence.
- Previous or concomitant treatment-related criteria:
- Patients who have taken a SYSADOA, SERM or a drug/dietary supplement containing glucosamine, chondroitin sulfate, diacerein or avocado-soybean extracts in the 3 months before randomisation
- Patients who have taken paracetamol in the 24 hours before randomisation or any other symptomatic analgesic drug, including NSAIDs (except aspirin up to 325 mg/day for cardiovascular prophylaxis), in the 48 hours before randomisation
- Patients who have received any corticosteroid treatment by any route of administration (other than inhalers or the ocular or auricular routes) in the month before randomisation
- Patients who have received an intra-articular steroid injection in the knee under study in the month before randomisation or patients who have received intra-articular hyaluronic acid in the target knee in the 6 months before randomisation
- Patients who have received any local or topical treatment on the target knee in the 2 weeks before randomisation
- Criteria related to concomitant medication:
- Hypersensitivity to paracetamol or NSAIDs
- Study product-related criteria:
- Known allergy to the study treatments or to any of its ingredients.
- Other criteria:
- Patients likely to be unable to comply with the protocol instructions and/or treatment, in the investigator's opinion
- Patients who have taken part in a clinical trial in the preceding 2 months or taking part in a trial at the time of randomisation
- Patients linguistically or mentally incapable of understanding the nature, objectives and possible consequences of the study; or who refuse to be subject to its limitations
- Patients who are family or colleagues (secretary, nurse, technician, etc.) of the investigator.
- Women: pregnant or breastfeeding
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2020
Estimated Enrollment :
175 Patients enrolled
Trial Details
Trial ID
NCT03762408
Start Date
December 15 2017
End Date
May 29 2020
Last Update
March 23 2021
Active Locations (18)
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1
Clínica Diagonal
Esplugues de Llobregat, Barceloma, Spain, 08950
2
Consell calatà de l'Esport
Esplugues de Llobregat, Barcelona, Spain, 08950
3
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
4
Clínica Novo Sancti Petri
Chiclana de la Frontera, Cádiz, Spain, 11139