NCT01618708已完成不适用
A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip
Genzyme, a Sanofi Company96 个研究点 分布在 2 个国家目标入组 357 人开始时间: 2012年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 357
- 试验地点
- 96
- 主要终点
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
研究概览
简要总结
The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant had symptomatic osteoarthritis (OA) in the target joint
- •The participant had a diagnosis of primary OA of the hip at Screening according to the American College of Rheumatology (ACR) Criteria
- •The participant, if female and of childbearing potential, must had a negative pregnancy test and had taken oral contraceptives for at least 1 month prior to treatment and continued for the duration of the study (up to and including the final study visit), or agreed to use 2 forms of contraception (e.g., condoms plus spermatocide), otherwise females must be surgically sterile, or postmenopausal for at least 1 year
排除标准
- •The participant had symptomatic OA in the contralateral hip with a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 numerical rating scale (NRS) score of ≥ 4 at Screening (symptomatic OA with a WOMAC A1 NRS score of 0-3 in the contralateral hip was allowed)
- •The participant if a woman was pregnant, lactating, or unwilling to use adequate contraception
- •The participant had prior viscosupplementation therapy in the target hip joint within 26 weeks of Screening
- •The participant had a known history of hypersensitivity to avian protein or any components of hyaluronan-based injection devices
- •The participant had a known history of hypersensitivity to steroids, lidocaine, and/or acetaminophen
- •The participant had a known history of hypersensitivity to injected contrast agent at a previous radiological examination (e.g., computed tomography [CT] scan, angiogram, etc.), or known history of hypersensitivity to shellfish or iodine, or any other impediment to the hip injection procedure
- •The participant had active infection in the area of the injection site
- •The participant had any major surgery, arthroplasty or arthroscopy in the target hip or lower extremities within 26 weeks of Screening, or planned surgery in the lower extremities throughout the duration of the study infectious complications
- •The participant used an investigational drug, device or biologic within 12 weeks of Screening
- •The participant had any significant medical condition that the Investigator feels would interfere with study evaluations and study participation
结局指标
主要结局
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 Subscore (Walking Pain) Over 26 Weeks
时间窗: From baseline to Week 26
WOMAC Numerical Rating Scale (NRS) 3.1 questionnaire is a health status measure questionnaire of 24 questions comprising 3 subscales (pain, stiffness and physical function). WOMAC A1 (measure of pain during walking on a flat surface) was measured on 11-point (NRS) ranging from 0 (none) to 10 (extreme), where lower score represents lower pain and higher score represents higher pain.
次要结局
- Change From Baseline in WOMAC A Score Over 26 Weeks(From Baseline to Week 26)
- Change From Baseline in Patient Global Self-Assessment (PTGA) Score Over 26 Weeks(From baseline to Week 26)
- Percentage of WOMAC A1 Responder Over 26 Weeks(From Baseline to Week 26)
研究者
研究点 (96)
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