NCT02010918已完成3 期
A Phase III, Multicenter, Randomized, Parallel, Open Label and Comparative Study to Evaluate the Efficacy of 500 mg Glucosamine Sulfate (GS) / 400 mg Chondroitin Sulfate (CS)Capsules and 1500 mg GS / 1200 mg CS Sachet Compared With Cosamin DS® Capsule in Treatment of Knee Osteoarthritis..
Ache Laboratorios Farmaceuticos S.A.1 个研究点 分布在 1 个国家目标入组 922 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 922
- 试验地点
- 1
- 主要终点
- Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .
研究概览
简要总结
The purpose of this study is to determine whether 500 mg Glucosamine Sulfate / 400 mg Chondroitin Sulfate Capsules and 1500 mg Glucosamine Sulfate / 1200 mg Chondroitin Sulfate Sachet is effective and safe compared Cosamin DS ® Capsule in Treatment of Knee Osteoarthritis.
详细描述
The Groups receive treatment for 16 weeks. The study is realized in 16 sites in Brazil.
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
- None
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
- •Male or female patient, older than 40 years of age, with knee osteoarthritis, based on clinical and radiological criteria (Kellgren-Lawrence grade 2 - 3), as specified:
- •Pain on movement of the affected knee for more than 15 days in the previous month with at least partial relief at rest;
- •Presence of osteophytes at least 1 mm in radiological imaging;
- •Knee osteoarthritis symptoms for at least six months prior to randomization.
排除标准
- •Concomitant arthropathy that may confuse or interfere with assessing the efficacy or pain;
- •Patellar disease isolated, with primary symptoms of pain in the anterior knee, in the absence of radiological findings already described;
- •History of significant injury on collateral ligament, or anterior cruciate, or meniscus of the joint studied, with surgery, or immobilization for at least 3 weeks;
- •Arthroscopy of the affected knee in last 6 months;
- •Serum creatinine ≥ 1.8 mg/dL;
- •Diagnosis of diabetes mellitus;
- •Presence of any serious disease that could compromise the study, at the investigator discretion;
- •History of adverse event or allergy to acetaminophen, glucosamine sulfate or chondroitin sulfate;
- •Inability to understand and report the study questionnaire and the Visual Analogic Scale;
- •Inability to understand and consent to participate in this clinical study, expressed by signing the Informed Consent (IC);
- •Woman in pregnancy.
- •If female of childbearing potential, has a negative urine pregnancy test at Visit 0 and do not use, or do not agree to use, for the duration of the study, a medically acceptable form of contraception as determined by the investigator;
- •Alcohol intake ( > 3 doses/day);
- •Oral or intramuscular corticosteroids four weeks prior to study entry;
- •Intra-articular injections with corticosteroids, into the studied knee, within the past three months;
- •Intra-articular injections in any other joint within the past four weeks;
- •NSAID users that don´t respect the washout period. Low-dose aspirin (325 mg or less, once daily) is allowed for cardio-protective benefit;
- •Intra-articular injections of hyaluronic acid within the past 12 months;
- •Use of topical analgesic in the joint studied or any other oral analgesic (with the exception of acetaminophen and other NSAID) two weeks prior to randomization;
- •Implementation of any other medical treatment for osteoarthritis one month prior to study entry;
- •Participation in last one year of clinical protocols, unless it can be direct benefit to patient;
- •Use of glucosamine and/or chondroitin sulfate three and six months prior the study entry, respectively;
- •Initiation of physical therapy two months prior to the study period;
- •Use of tetracycline and oral anticoagulants;
- •Use of vitamin D in doses in doses above the recommended;
- •Patients in alternative therapies;
- •Allergy to sulfonamides;
- •Presence of psychiatric disorders that could compromise the study.
研究组 & 干预措施
glucosamine sulfate /chondroitin sulfate capsule
Experimental
500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.
干预措施: glucosamine sulfate /chondroitin sulfate - capsules (Drug)
glucosamine sulfate /chondroitin sulfate - sachet
Experimental
1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.
干预措施: glucosamine sulfate /chondroitin sulfate - sachet (Drug)
Cosamin DS®
Active Comparator
500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.
干预措施: Cosamin DS® (Drug)
结局指标
主要结局
Change from baseline in pain intensity in the affected knee and variation of Lequesne's index and VAS at week 16 .
时间窗: BASELINE, week 16
次要结局
- Percentage of Participants with any Decrease in Pain Visual Analogue Scale (VAS)(baseline, week 16)
研究者
研究点 (1)
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