临床试验/NCT00496392

NCT00496392已完成3 期

An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer

Nycomed2 个研究点分布在 1 个国家目标入组 115 人开始时间: 2007年1月1日最近更新: 2012年5月7日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Nycomed
入组人数: 115
试验地点: 2
主要终点: Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary:

• To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients.

Secondary:

To compare patients' general impression and preference of NF and Actiq
To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid
To assess safety and tolerability of NF

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain.
•Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months.
•Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed.
•Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed.
•Previous use of Actiq is accepted.

排除标准

未提供

结局指标

主要结局

Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch

时间窗: 26 weeks

次要结局

• Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t(26 weeks)

研究者

发起方

Nycomed

申办方类型

Industry

研究点 (2)

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