Non-Inferiority Clinical Trial On The Efficacy And Safety Of Chondroitin Sulfate And Glucosamine Hydrochloride In Combination Versus Celecoxib In Patients With Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 606
- 试验地点
- 1
- 主要终点
- WOMAC Pain Subscale
研究概览
简要总结
The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).
详细描述
The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale in knee OA patients with moderate to severe pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •At least 40 years of age
- •Primary OA of the knee according to the American College of Rheumatology (ACR) criteria
- •OA of radiological stages II or III according to Kellgren and Lawrence
- •Patients with moderate-severe knee pain
排除标准
- •Subjects with active malignancy of any type or history of a malignancy within the last five years
- •Concurrent arthritic disease (antecedents and/or current signs) that could confound or interfere with the evaluation of pain efficacy such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease
- •Pain in other parts of the body greater than the knee pain that could interfere with the evaluation of the index joint
- •Patients with fibromyalgia
- •Subjects with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious diseases of the heart
- •Subjects with high risk of cardiovascular (CV) events
- •Subjects with any active acute or chronic infections requiring antimicrobial therapy, or serious viral (e.g., hepatitis, herpes zoster, HIV positivity) or fungal infections
- •Subjects with a history of recurrent Upper Gastrointestinal (UGI) ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect
- •Subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication
- •Washout period for OA treatments before beginning the study.
研究组 & 干预措施
Chondroitin/Glucosamine (Droglican)
Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.
Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.
干预措施: Chondroitin/Glucosamine (Droglican) (Drug)
Celecoxib
Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
干预措施: Celecoxib (Drug)
结局指标
主要结局
WOMAC Pain Subscale
时间窗: 6 months
Western Ontario \& McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale Score Range: 0 (no pain) - 500 (maximum pain) The study was designed such that the outcome of primary interest is knee pain related to OA. The measure selected to best evaluate this is an improvement in the WOMAC pain subscales. This subscale consists of 5 items which assesses the pain during walking, using stairs, in bed, sitting or lying, and standing.
次要结局
- WOMAC Stiffness Subscale(6 months)
- WOMAC Function Subscale(6 months)
- Huskisson's VAS(6 months)
- Percentage of Participants With Response as Defined by Outcome Variables for Osteoarthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI)(6 months)
- Percentage of Presence of Joint Swelling(6 months)
- Percentage of Presence of Joint Effusion(6 months)
- Number of Adverse Events Defined by Relationship With Treatment(6 months)
- Patient's and Investigator's Global Assessment of Response to Therapy(6 months)
- Number of Participants With at Least One Adverse Events(6 months)
- Biomarker Analysis(6 months)
- Consumption of Rescue Medication(6 months)
- Patient's Global Assessment (PGA) and Investigator's Global Assessment (IGA) of Disease Activity(6 months)
- Health Status According to EuroQoL(6 months)