NCT00228605已完成3 期
An Open-Label 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of OraVescent Fentanyl Citrate for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Chronic Noncancer Pain
Cephalon72 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2005年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 72
- 主要终点
- Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of OraVescent fentanyl for the potential treatment of breakthrough pain episodes in patients who have chronic noncancer pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain diagnosis
- •Opioid tolerant
- •Has on average 1-4 breakthrough pain episodes per day
排除标准
- •Drug abuse history
- •Cardiopulmonary disease
- •Monoamine oxidase inhibitors (MAOIs)
- •Expected to have surgery to relieve the pain
结局指标
主要结局
Safety and tolerability when used over a 12-month period for the management of breakthrough pain in opioid tolerant patients
次要结局
- Assess the patients' quality of life through questionnaires
- Assess the patients' overall medication preferences
- Assess the patients' overall medication performance
研究者
研究点 (72)
Loading locations...
相似试验
已完成
3 期
Study to Evaluate the Efficacy and Safety of OraVescent Fentanyl Citrate Treatment for the Management of Breakthrough Pain in Opioid-Tolerant Patients With Noncancer-Related Chronic PainPainNCT00343733Cephalon120
已完成
2 期
Phase II Clinical Trial of Fentanyl Transdermal Matrix Patch, in the Management of Cancer Pain- Assessment of Effectiveness, Safety and Pharmacokinetics -Pain, IntractableNCT00216658Janssen Pharmaceutical K.K.87
已完成
3 期
Treatment of Breakthrough Pain in Opioid Tolerant Cancer PatientsPainCancerNCT00105287Cephalon100
终止
3 期
Open-Label Study to Evaluate the Effect of Treatment With Fentanyl Buccal Tablets on Pain Anxiety Symptoms When Used for the Management of Breakthrough PainPainChronic PainBreakthrough PainNCT00387010Cephalon218
终止
3 期
Fentanyl Transdermal Matrix Patch ZR-02-01 to Treat Chronic, Moderate to Severe Non-Malignant PainPainNCT00126763ZARS Pharma Inc.105