Knee osteoarthritis with moderate to severe pain. MedDRA version: 14.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: ARACONDRO
Pharmaceutical Form: Chewable tablet
CAS Number: 9007-28-7
Other descriptive name: CHONDROITIN SULFATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
ARAFARMA GROUP, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Osteoarthritis of the knee diagnosed by the diagnostic criteria of the ACR. 2. Pain with moderate to severe score between 301 and 400 in the WOMAC subscale pain, or well with a score greater than 4 cm visual analogue scale of 10 cm. 3. Diagnosis clinical pain and functional limitation in the 6 months prior to the inclusion. 4. Male or Felame patients, aged over 40 years. 5. Ability and commitment to compliance with study procedures and scheduling follow-up visits. 6. Intellectual Ability to understand and sign the Informed Consent document. 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 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 251
Exclusion criteria
Exclusion criteria: 1. Allergy to shellfish or any component of the study medication. 2. Known hypersensitivity to the active substance or any excipients of Celecoxib. 3. Cardiovascular disease incompatible with the use of Celecoxib. 4. Joint or bone disease known as chondrocalcinosis, Paget's disease, arthritis rheumatoid arthritis, psoriatic arthritis, acromegaly, hemochromatosis or Wilson's disease. 5. History or presence of active rheumatic disease that could be responsible for a secondary osteoarthritis. 6. Severe swelling of the joint confirmed by physical examination, speed ESR> 40 mm / h and positive rheumatoid factor. 7. Index of body mass index (BMI) greater than 30 kg/m2. 8. Hematologic or metabolic, liver or kidney abnormalities at the discretion of Investigator, may hinder a patient's serious commitment to adhere to treatment during the study period. 9. Administration intra-articular or systemic corticosteroids in the last 3 months. 10. Previous use of SYSADOAs in the last 6 months. 11. History of significant trauma or surgery on the affected joint. 12. Arthroplasty of the affected joint arthroplasty or programming in the next 6 months. 13. Use of narcotic analgesics. 14. Known hypersensitivity to sulphonamide and paracetamol. 15. Active peptic ulceration or gastrointestinal bleeding. 16. Patients who have experienced asthma, acute rhinitis, nasal polyps, edema urticaria or other allergic-type reactions after taking aspirin aspirin or other nonsteroidal antiinflammatory drugs (NSAIDs), including COX-2. 17.Inflammatory Bowel Disease. 18 Estimated creatinine clearance of <30 ml / min 19 Serum albumin <25 g / L 20. Any circumstance which, at the discretion of the investigator, would prevent the patient to follow rigorously the the study protocol. 21. Women of childbearing potential not using a reliable method of birth control. 22. Women who are pregnant or nursing mothers. 23. Patients who are using other investigational agent for the treatment trial. 24. Patients who are in the process of litigation to get the disability or incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of combination of chondroitin sulphate and Glucosamine hydrochloride in a single chewable tablet versus placebo in the symptomatic treatment of knee osteoarthritis, in patients with moderate to severe pain, using Celecoxib effectiveness as a positive control.;Secondary Objective: Assessment of the improvement in pain and functionality of knee, using the sub-scales of the WOMAC questionnaire, safety of treatment, use of rescue medication, patient Quality of Life, responders according to OMERACT-OARSI criteria 2004.;Primary end point(s): Decrease of 26% in the total score of the questionnaire WOMAC score at 6 months of treatment with initial baseline.;Timepoint(s) of evaluation of this end point: Decrease of questionnaire WOMAC score at 6 months of treatment (End of Study). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Improvement in pain in the WOMAC subscale. 2. Improvement in stiffness in the WOMAC subscale. 3. Improvement in the function in the WOMAC subscale. 4. Evaluation of the safety of each treatment group. 5. Assessment by the patient global evolution of osteoarthritis. 6. Use of rescue medication. 7. Use of other concomitant medications: gastroprotective, anxiety and / or antidepressants. 8. Presence of swelling or effusion, or both. 9. Quality of life according to the HAQ form. 10. Valuation global medical 11. Responder Patients according to OMERACT-OARSI criteria 2004.;Timepoint(s) of evaluation of this end point: From 1 to 5 and from 9 to 11: End of Study. From 6 to 8: During the course of the study. | — |
Countries
Spain
Contacts
Public ContactClinical Operations Department
Recerca Clinica SL
Outcome results
None listed