Comparative study of efficacy and safety of GO-ON and Hyalgan in patients with symptomatic osteoarthritis of the knee.
- Conditions
- Patients with symptomatic osteoarthritis of the knee.MedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis
- Registration Number
- EUCTR2008-003875-35-DE
- Lead Sponsor
- Rottapharm SpA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Patients who fulfilled the following criteria are eligible:
• patients who signed the informed consent to participate in the study,
• female/male, age from 50 to 80 year inclusive,
• patients with femorotibial OA of the knee. The diagnosis of knee osteoarthritis
will be based on the clinical and radiographic classification criteria developed
by the American College of Rheumatology (ACR) (Altman R. et al., 1986), i.e.:
- Knee pain,
- X-ray osteophytes and
- at least one of 3:
age >50 years and/or
morning stiffness <30 minutes duration
and/or crepitus on active motion,
• patients with knee OA symptoms for at least six months and who failed to
respond (i.e. did not respond sufficiently) to analgesics and/or regular NSAIDs,
or are proved to be intolerant to the regular use of NSAIDs or weak opioids
analgesics,
• patients with a global pain score = to 40 mm on a 0-100 mm VAS and a
WOMAC pain subscale score = 25 mm on a 0-100 normalized scale,
• patients with Lequesne’s Index = 4,
• patients with radiographic stage II or III according to the Kellgren and
Lawrence radiological classification (the relevant X-ray might have been
performed within the 12 months preceding the screening visit),
• patients having X-ray or MRI confirmation of OA in the non-target (contralateral)
knee, may be enrolled in the trial as long as the target knee is the more
symptomatic knee and meets the criteria listed above. Pain in the non-signal
knee must be limited to <30mm at baseline on a 0-100 mm Huskisson VAS,
• patients treated with SYSADOAs are eligible if the dosage has been stable at
least three months prior the screening visit
• patients must be covered by the National Social Security insurance system
(only for French Patients).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
The main exclusion criteria are the following:
•isolated or predominantly symptomatic femoropatellar OA of the knee,
•evidence of secondary osteoarthritis,
•rheumatic diseases other than osteoarthritis,
•with clinical joint effusion” of the target knee on the day of screening,
•history of allergy or known hypersensitivity to hyaluronic acid and/or hypersensitivity to any of the components of the products under study,
•patients in which both rescue medications (paracetamol/NSAID) are contraindicated,
•any significant health problem,
•known hepatic function abnormalities,
•skin infection or disease at the injection site,
•use of any experimental drug within the previous 3 months,
•obese patients (BMI =32),
•patients who have been treated with:
-intra-articular steroid during the previous month or systemic steroid drugs within the 3 months preceding randomization and/or
-intra-articular hyaluronic acid in the target knee during the previous 12 months,
•ongoing anticoagulant treatment (except patients on low dose aspirin, not exceeding 325 mg per day),
•patients with symptomatic hip OA homolateral to the target knee,
•pregnant or lactating women, and women of childbearing potential (using adequate contraceptive method for at least 1 year) not willing to keep on using adequate contraceptive method for the duration of the study,
•perceived inability/unwillingness to fully comply with all protocol requirements.
• Patients who underwent extensive surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) and/or uncomplicated meniscectomy if performed within the last 12 months before the screening visit of the target knee. [Even if meniscectomy is a RISK FACTOR for knee OA, it is not considered an exclusion criteria if performed > 12 months before the screening visit].
• Patients who have received any investigational drug/device within 3 months prior to the screening visit and/or patients who are scheduled to take part in other clinical trial during the course of this trial.
• Patients with a severe concomitant disease at any organ or apparatus (including acute or chronic infective diseases) that may interfere with the free use and evaluation of the affected knee for the 6 months course of the trial and/or current treatment or treatment within the previous 2 years prior to the screening visit for any malignancy (excluding basal cell or squamous cell carcinoma of the skin).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the non-inferiority of GO-ON in comparison to Hyalgan on knee pain in patients with symptomatic Knee OA at 26 weeks.;Secondary Objective: •to compare the efficacy of GO-ON and Hyalgan on secondary efficacy parameters.<br>•to identify Responder patients to the OMERACT-OARSI, MCII and PASS criteria.<br>•to evaluate the safety of the studied products in patients with symptomatic knee OA. ;Primary end point(s): The primary objective of the statistical analysis will be the assessment of non-inferiority of GO-ON with respect to Hyalgan in the control of knee pain, 26 weeks after the first injection. Mean variation of the mean WOMAC pain (rated on a 0 – 100 mm Visual Analogue Scale), calculated on the PP population, will be used as primary efficacy parameter.<br>GO-ON will be declared non-inferior to Hyalgan, rejecting the Null Hypothesis, if the lower limit of the 95% Confidence Interval of the difference will lie above the lower equivalence (non-inferiority) margin (-9 mm).<br>
- Secondary Outcome Measures
Name Time Method