NCT00377806已完成4 期
A One Week, Double-Blind, Adaptive, Randomized, Multicenter Study to Compare the Efficacy, Safety and Tolerability of Topical Diclofenac Gel Versus Placebo in Patients With Superficial Thrombophlebitis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of topically administered diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size of erythema along the superficial vein)
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
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with indication of topical treatment for inflammatory, painful superficial thrombophlebitis of the upper limb
- •Spontaneous or iatrogenic superficial thrombophebitis of the upper limb
排除标准
- •Hypersensitivity to the study drug, to actylsalicyclic acid and other non-steroidal antirheumatic agents and to the ingredients of the gel
- •Paitents who had developed asthma, skin reactions or acute rhinitis to acetylsalicylic acid or other non-steroidal antirheumatic agents in the past
- •Therapy with varicose vein remedies, antithrombotic or antiphlogistic agents as well as corticosteroids for more than 7 days prior to study start
- •Acute deep vein thrombosis and thrombophlebitis extending into other deep veins
- •Other protocol-defined exclusion criteria may apply
结局指标
主要结局
The area under the curve (AUC) of the symptom score (pain, temperature and size of erythema along the superficial vein)
次要结局
- Patient's global assessment of drug effect at each visit
- Physician's global assessment of drug effect at each visit
- AUC of assessment of pain (visual analog scale) between treatment day 1 and day 5
- AUC of assessment of inflammatory area of the superficial thrombophlebitis between treatment day 1 and 5
- AUC of assessment of temperature of inflammatory area around superficial thrombophlebitis between treatment day 1 and 5
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Diclofenac Patch for the Treatment of Acute Pain Due to Mild to Moderate Wrist Sprain, Strain or ContusionAcute PainNCT00869063Cerimon Pharmaceuticals214
已完成
3 期
Efficacy and Safety of Diclofenac Sodium Gel (DSG) in Knee OsteoarthritisOsteoarthritis of the KneeNCT00426621Novartis420
已完成
4 期
Efficacy and Safety of Diclofenac 1.16% Gel in Subjects With Acute Neck PainNeck PainNCT01335724Novartis72
已完成
3 期
A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental PainPost Operative Dental PainNCT02476422Novartis Pharmaceuticals328
已完成
3 期
Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Applied 4 Times Daily in Subjects With Acute Ankle SprainAnkle SprainNCT01255423Novartis206