An open, randomized study to investigate the plasma and synovial fluid concentrations of glucosamine before and after repeated doses of crystalline glucosamine sulfate administered as oral soluble powder formulation presented as a sachet (1500 mg o.a.d.) and to assess the efficacy of glucosamine vs pure analgesic (paracetamol 1000 mg t.i.d.) in patients with knee osteoarthritis. - ND
- Conditions
- Joint disordersMedDRA version: 9.1Level: LLTClassification code 10048794Term: Gonarthrosis
- Registration Number
- EUCTR2007-001501-13-IT
- Lead Sponsor
- ROTTAPHARM / ROTTA RESEARCH LABORATORIUM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1.Male and female Caucasian, out-patients with a diagnosis of primary knee osteoarthritis, aged 45-75 years. 2.The diagnosis of knee osteoarthritis will be based on the clinical classification criteria developed by ACR; knee pain and at least one of the three clinical findings: Age >50 years; morning stiffness <30 minutes duration; crepitus on active motion. 3.Lequesne index at the randomization visit of at least 4 points. 4. Apart for knee osteoarthritis, good general health, as determined at the screening examination by medical history and physical examination. 5. Able to understand and willing to sign the Informed Consent Form.
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
1.Patients who fail to meet any of the inclusion criteria. 2.Patients below 45 or over 75 years of age. 3.Patients not meeting the ACR diagnostic criteria for knee osteoarthritis. 4.Patients with a Lequesne index at randomization lower than 4. 5.Patients with secondary osteoarthritis. 6. Patients with excessive varus or valgus knee deformity. 7.Patients with rheumatic diseases other than osteoarthritis or periarticular problems, or other disease that may affect assessments of the knee joints. 8.Patients who underwent arthroscopy of the affected knee joint(s) within one year. 9.Patients who underwent extensive surgery, including meniscetomy, of the knee joint(s). 10.Patients with any significant injury of the affected knee joint(s) within six months of the trial start. 11.patients with a BMI higher than 35 kg/m2. 12.Any clinically significant abnormalities as judged by the Principal Investigator from the screening examinations. 13.Any history or clinical findings, which may interfere with the pharmacokinetics of drugs, such as gastrointestinal disease or surgery, alteration in the composition of plasma proteins or any sign of a reduced liver or kidney function. 14.Patients with history of diabetes mellitus or with fasting blood glucose levels>7.0 mmol/L. 15.Patients with severe concomitant diseases at any organ or aparatus. 16.Patients who underwent tidal lavage of the knee joint(s) within three months from randmization. 17.Patients who have been treated with intra-articular, or topical, or systemic steroid drugs within the three months preceding randomization. 18.Any patients who received anticoagulant drugs or any other medication within two weeks prior to the first day of dosing that, as judged by the Principal Investigator might interfere with the study drug. 19.Patients who have been treated with glucosamine sulfate or other drugs considered specfic for osteoarthrosis (e.g. chondroitin sulfate) within the six months preceding the randomization. 20.Patients treated with biological prostheses (hyaluronic acid and its derivatives) who had not interrupted such treatment at least six months before randomization. 21.Patients performing jobs or activities which, in the opinion of the investigator, may affect the evaluations in this study. 22.Patients with a history of alcohol or drug abuse, or affected by psychiatric disorders, or any factor limiting their ability to cooperate in this study. 23.Patients with any history of chronic abuse of analgesics, alcohol, tranquillizers, opioids or known drug dependence. 24.Patients with a known hypersensitivity to a paracetamol or glucosamine or ibuprofen. 25.History or presence of allergic reactions against drugs, unless judged clinically insignificant by the Principal Investigator/study physician. 26.History or suspicion of inalbility to cooperate adeguately. 27.Pregnant women. Women of child-bearing potential must take an adequate contraception method. 28.Patients with a history of peptic ulcer disease, or any other contraindications to NSAIDs used in this trial as rescue medication. 29.Patients unable to understand the aims, the procedures or the possible hazards of the study; patients not collaborating or not reliable for collaboration in long-term study. 30.Patients not willing or unable to give their informed consent.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the plasma and synovial fluid concentrations of glucosamine before and after multiple oral doses of crystalline glucosamine sulfate administered as an oral soluble powder presented as sachet. To assess the efficacy and safety of glucosamine sulfate, in continuous treatment for 6 months, on osteoarthritis of the knee symptoms in comparison with paraceamol.;Secondary Objective: ;Primary end point(s): To assess glucosamine concentrations in plasma and synovial fluid determined at baseline and after 1, 6 and after 12 months, in patients not responding after 6 month of treatment with glucosamine sulfate.
- Secondary Outcome Measures
Name Time Method