NCT00635063终止3 期
A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects With Malignancies
Sosei1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2008年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
研究概览
简要总结
Purpose:
The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. The efficacy evaluation criteria have been designed to determine whether AD 923 provides superior analgesia compared with MSIR as measured by the primary endpoint.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •The subject is a male or female, at least 18 years of age.
- •The subject has a malignancy, is receiving opioid therapy for his or her underlying persistent cancer pain, and is tolerant to the opioid therapy.
- •The subject typically has 2 to 6 episodes of target BTP per day that require treatment.
- •The subject has a life expectancy of >3 months.
- •The subject or his or her caregiver has easy, reliable access to a telephone.
排除标准
- •The subject is a female who is pregnant or lactating.
- •The subject has any respiratory or cardiac condition that, in the opinion of the investigator, may be clinically worsened by opioids.
- •The subject has any allergy to the AD 923 product or excipients, namely: fentanyl, dehydrated alcohol, menthol, saccharin, and citrate buffer; or to the MSIR product excipients, namely: morphine sulphate, lactose (anhydrous), pregelatinized maize starch, povidone, purified water, magnesium stearate, talc, and tablet coatings.
- •The subject has any neurological or psychiatric disease that, in the opinion of the investigator, would compromise data collection.
- •The subject has uncontrolled or rapidly escalating pain.
- •The subject has any significant laboratory test results that, in the opinion of the investigator, will compromise subject safety or the conduct of the study.
- •The subject has plans to undergo chemotherapy, radiotherapy, or surgery during the treatment period. The exception is that subjects may continue chemotherapy over the study period, provided it is not expected to alter the pain state or response to pain medication.
研究组 & 干预措施
AD 923
Experimental
干预措施: AD 923 (Drug)
MSIR
Active Comparator
干预措施: AD 923 (Drug)
结局指标
主要结局
To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
次要结局
- To assess the safety and tolerability of AD 923 in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
研究者
研究点 (1)
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