NCT00426621已完成3 期
A 12-Week, Randomized, Double-Blind, Multi-Center, Vehicle-Controlled, Parallel Group Study to Assess the Efficacy and Safety of the Diclofenac Sodium Gel 1% for the Relief of Signs and Symptoms in Patients With Osteoarthritis of the Knee.
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
- Novartis
- 入组人数
- 420
- 试验地点
- 61
- 主要终点
- pain in the target knee (WOMAC pain index);
研究概览
简要总结
This study will test the efficacy and safety of topical diclofenac sodium gel in the treatment of knee osteoarthritis.
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)
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
- •Osteoarthritis of the knee
排除标准
- •Other rheumatic disease, such as rheumatoid arthritis
- •Active gastrointestinal ulcer during the last year
- •Known allergy to analgesic drugs
- •Other protocol defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
干预措施: Diclofenac Sodium Gel (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
pain in the target knee (WOMAC pain index);
functional capacity in the target knee (WOMAC function index); and
global rating of benefit (100 mm Visual Analogue Scale, VAS).
次要结局
- laboratory evaluations.
- Efficacy of Diclofenac Sodium Gel 1% with regard attainment of:
- Low pain intensity in either knee; and
- Low functional impairment in either knee.
- Safety of Diclofenac Sodium Gel 1% assessed by:
- monitoring adverse events; and
研究者
研究点 (61)
Loading locations...
相似试验
已完成
2 期
12-Week Study in Adult Subjects With AsthmaAsthmaNCT01516073Dey629
已完成
2 期
12-Week, Double-Blind, Placebo-Controlled Study of 20 and 60 mg/Day Istradefylline in Parkinson's Disease Patients on Levodopa/CarbodopaParkinson's DiseaseNCT00456794Kyowa Kirin, Inc.325
已完成
不适用
A 12-weeks Study to Evaluate Sulforaphane in Treatment of Autism Spectrum DisorderAutism Spectrum DisorderNCT02879110Central South University110
已完成
2 期
A Study to Evaluate the Safety and Effectiveness of Doxercalciferol Capsules in Participants With Moderate to Severe PsoriasisModerate to Severe Chronic Plaque PsoriasisNCT00601107Genzyme, a Sanofi Company111
进行中（未招募）
3 期
Determine Effectiveness of Anifrolumab In SYstemic Sclerosis (DAISY)SclerodermaSystemic SclerosisNCT05925803AstraZeneca314