EUCTR2011-005398-22-ES进行中（未招募）不适用
A randomized, multicenter, double-blind, double dummy and parallel study to evaluate the efficacy of the combination of Chondroitin sulfate and Glucosamine hydrochloride in a single dose chewable tablet versus Placebo, using Celecoxib as an active control in patients with knee osteoarthritis with moderate to severe pain. - ARACONDRO
ARAFARMA GROUP, S.A.0 个研究点开始时间: 2012年1月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
- •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.
研究者
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