NCT00988091已完成3 期
A 26 Week, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Single Intra-Articular Injection 1.2% Sodium Hyaluronate for Treatment of Painful Osteoarthritis of the Knee, With Optional 26-Week Open-Label Safety Extension
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 34
- 主要终点
- Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26
研究概览
简要总结
Subjects with chronic osteoarthritis of the knee will be assigned to receive an injection of either 1.2% sodium hyaluronate or buffered saline to evaluate its effectiveness and safety for 26 weeks. After 26 weeks, subjects can elect to receive a second injection of 1.2% sodium hyaluronate and be followed for another 26 weeks.
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
- Triple (Participant, Care Provider, 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
- •Chronic osteoarthritis (OA) of target knee confirmed by American College of Rheumatology (ACR) Criteria.
- •Pain due to OA in target knee present for at least 6 months.
- •During Screening and Baseline visits, subjects will require a visual analog scale (VAS) score (100 mm) of ≥ 41 mm and ≤ 90 mm, recorded immediately following a 50-foot walk, AND at Baseline, cannot have decreased >10mm (improvement) from Screening.
- •A bilateral standing anteroposterior (AP) X-ray confirming OA of the target knee.
- •Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
- •Ability to perform procedures required of the pain index evaluations (unassisted walking 50 feet on a flat surface and going up and down stairs).
- •Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions.
- •Signed Subject Informed Consent Form
排除标准
- •Any major injury (including sports injuries) to the target knee within the prior 12 months.
- •Any surgery to the target knee, hip and contralateral hip within the prior 12 months.
- •Major and minor articular procedures
- •Inflammatory arthropathies such as rheumatoid arthritis, lupus arthropathy, or psoriatic arthritis.
- •Gout or calcium pyrophosphate (pseudogout) diseases of the target knee that have flared within the previous 6 months.
- •X-ray findings of acute fractures, severe loss of bone density, avascular necrosis, and/or severe bone or joint deformity in the target knee.
- •Osteonecrosis of either knee.
- •Fibromyalgia, pes anserine bursitis, lumbar radiculopathy, and/or neurogenic or vascular claudication.
- •Significant anterior knee pain due to diagnosed isolated patella-femoral syndrome or chondromalacia in the target knee.
- •Significant target knee joint infection or skin disorder/infection within the previous 6 months prior to study enrollment.
- •Symptomatic OA of the hips, spine, or ankle, if it would interfere with the evaluation of the target knee.
- •Known hypersensitivity to acetaminophen, sodium hyaluronate, or phosphate buffered saline solution.
- •Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period.
- •Recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders.
- •Vascular insufficiency of lower limbs or peripheral neuropathy severe enough to interfere with the study evaluation.
- •Current treatment or treatment within the previous 2 years prior to Screening for any malignancy unless specific written permission is provided by the Sponsor (excluding basal cell or squamous cell carcinoma of the skin).
- •Chronic liver disease and active liver disease based on liver profile of aspartate aminotransferase (AST), alanine transaminase (ALT), and conjugated bilirubin >2 times the upper limit of normal.
- •Renal insufficiency based on serum creatinine >2.0 mg/dL.
- •Any clinically significant laboratory value based on clinical history that the Investigator feels may affect the study evaluation.
- •Any intercurrent chronic disease or condition that may interfere with the completion of the 6-month (or 12-month) follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition.
- •Current alcoholism, and/or any known current addiction to pain medications.
- •Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study.
- •Any psychiatric illness that would prevent comprehension of the details and nature of the study.
- •Participation in any experimental device study within 6 months prior to the Screening, or an experimental drug study within 1 month prior to the Screening
结局指标
主要结局
Change From Baseline in the Visual Analogue Score (VAS) Pain Score of the 50-foot Walk Test at Week 26
时间窗: Day 0 (baseline) through Week 26
The level of pain is estimated by the participant following a walk of 50 feet in length which is observed by the investigator. Pain estimates were recorded on a 100 millimeter visual analog scale. A score of 0 millimeters means there was no pain; a score of 100 millimeters means extreme pain. Change from baseline is calculated: week 26 VAS Pain Score - Baseline VAS Pain Score.
次要结局
- Change From Baseline in Western Ontario McMaster University Osteoarthritis Index (WOMAC) Disability Scores at Week 26(Day 0 (baseline), week 26)
- Percentage of Participants With a >=20mm Improvement Between Baseline and Week 26 on the 50 Foot Walk Visual Analogue Scale (VAS) Pain Score.(Day 0 (baseline), Week 26)
- Subjective Patient Assessment of Treatment at Week 26(Week 26)
- Number of Tablets of Rescue Medication Used Between Visits(Day 1 to week 26)
- Change From Baseline in Patient Global Assessment at Week 26(Day 0 (baseline), Week 26)
- Percentage of Observed Osteoarthritis Research Society International (OARSI30) Responders Using the Visual Analogue Scale (VAS) to Assess Pain Following a 50-foot Walk at Week 26(Day 0 (baseline), week 26)
研究者
研究点 (34)
Loading locations...
相似试验
已完成
3 期
A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease (CNVA237A2304)chronic obstructive pulmonary diseaseCOPD10038716NL-OMON34669ovartis32
进行中（未招募）
不适用
A 26-week treatment, randomized, double-blind, placebo-controlled, parallel group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease.chronic obstructive pulmonary disease (COPD)MedDRA version: 12.0Level: LLTClassification code 10010952Term: COPDEUCTR2009-013504-32-NLovartis Pharma Services AG800
已完成
1 期
Safety and Tolerability of NTX-101 in Korean Healthy VolunteersHealthy VolunteersNCT05041543Pinotbio, Inc.36
招募中
1 期
A study to evaluate the effect of food on the pharmakokinetics and cardiac function in male and female healthy volunteers who have been administered cannibidiol.ACTRN12619000443190Kalytera Australia Pty Ltd32
已完成
3 期
Study of Safety of QAW039 in Patients With Asthma Inadequately Controlled on Standard-of-care Asthma TreatmentAsthmaJPRN-jRCT2080223509ovartis Pharma K.K.200