Parallel-group Active Comparator, Double-blind, Randomized, Phase III Study to Assess Safety, Efficacy of Glucosamine Sulfate Plus Meloxicam vs Glucosamine Sulfate Plus Chondroitin Sulfate Primary Symptomatic Knee Osteoarthritis Treatment
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- To assess whether the efficacy of glucosamine + meloxicam sulfate treatment is superior to the efficacy of treatment with glucosamine sulfate + chondroitin sulfate in improving pain in subjects with symptomatic primary knee OA treated for 4 weeks.
研究概览
简要总结
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week, multicenter clinical study. Participants will be randomized 2: 2: 1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
详细描述
A multicenter, randomized, double-blind, parallel-group, placebo-controlled, and active-drug, 12-week treatment period, phase 3 comparative clinical study. Participants will be randomized 2:2:1 to receive the combination of glucosamine sulfate + meloxicam (experimental group), combination of glucosamine sulfate + chondroitin sulfate (active control group) or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant and Investigator
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 40 to 75 years (both inclusive).
- •Clinical and radiological diagnosis of primary (idiopathic) knee osteoarthritis according to the American College of Rheumatology (ACR) criteria.
- •Radiological classification of Kellgren and Lawrence of grades 2 or 3 on X-ray of the target knee.
- •Presence of painful symptoms in the target knee in the last 3 months due to osteoarthritis.
- •Visual analogue scale for evaluation of knee osteoarthritis pain by the research participant ≥ 40 mm at the screening visit.
- •Mean score ≥ 40mm on the "pain" subscale (0 to 100mm) on the target knee of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the randomization visit.
- •ACR functional class from I to III.
- •Signature of the Informed Consent Form before performing any study procedure.
排除标准
- •Diagnosis of septic arthritis, inflammatory arthritis (such as rheumatoid arthritis), gout, pseudogout, Paget's disease, dysplasias or congenital articular anomalies.
- •Severe joint misalignment in the target knee, defined by the researcher.
- •History of severe trauma or surgery (including arthroscopy) in the target knee within 6 months prior to the study selection visit.
- •Symptomatic osteoarthritis of the ipsilateral hip.
- •Use of non-steroidal anti-inflammatory, dipyrone, opioid or narcotic analgesics, collagen and herbal remedies for osteoarthritis from the screening visit, or a washout period for such drugs less than those defined by the protocol, prior to the visit randomization. The use of antidepressants and pain modulating medicinal products should not be started from the screening visit, but they should be kept stable during the study if they are already being used prior to the screening visit.
- •Oral, intravenous or intramuscular corticosteroid therapy within 30 days prior to study visit visit.
- •Intra-articular injection of corticosteroids, hyaluronic acid and / or platelet-rich plasma at the target knee within 6 months prior to the study selection visit.
研究组 & 干预措施
Placebo
Placebo administered once daily for 12 weeks
干预措施: Placebos (Drug)
glucosamine sulfate 1500mg and meloxicam 15mg (Eurofarma)
glucosamine sulfate 1500mg plus meloxicam 15mg combination, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.
干预措施: glucosamine sulphate 1500mg and meloxicam 15mg (Drug)
Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg
Glucosamine sulfate 1500mg plus Chondroitin Sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®), given once daily for 12 weeks.
干预措施: Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg (Drug)
结局指标
主要结局
To assess whether the efficacy of glucosamine + meloxicam sulfate treatment is superior to the efficacy of treatment with glucosamine sulfate + chondroitin sulfate in improving pain in subjects with symptomatic primary knee OA treated for 4 weeks.
时间窗: 4 weeks
Absolute variation of the "pain" subscale score of the WOMAC questionnaire (0 to 100mm) 4 weeks (V2) after starting treatment in relation to the basal score (VR);
次要结局
未报告次要终点