EUCTR2007-000559-32-HU进行中（未招募）不适用
A Multicentre, Open-Label, Extension Study to Investigate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) for the Treatment of Breakthrough Cancer Pain in Subjects with Malignancies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The subject met all eligibility criteria for Protocol P AD923 004 or Protocol P AD923 005.
- •The subject continues to take stable around-the-clock opioid therapy for chronic cancer pain, and continues to require therapy for episodes of BTP. The minimum dose of background opioid therapy should be 60 mg/day of morphine or morphine equivalent or 25 µg/hour transdermal fentanyl.
- •If female of childbearing potential, the subject has a negative urine pregnancy test. To be considered not of childbearing potential, the subject must be postmenopausal for at least 2 years, have had a hysterectomy or bilateral tubal ligation with resection, or be otherwise incapable of pregnancy. The subject must agree to continue practicing one of the following methods of contraception consistently: hormonal contraceptives, intrauterine device, spermicide and barrier, spousal/partner sterility, or is practicing abstinence and agrees to continue abstinence or to use an acceptable method of contraception from the above list if sexual activity commences.
- •The subject is able and willing to understand the study and cooperate with the study instructions.
- •The subject is able and willing to provide written informed consent.
- •The subject has a life expectancy of at least 2 months.
- •The subject or his or her caregiver must have easy, reliable access to a telephone.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The subject is a female who is pregnant or lactating.
- •The subject has developed any respiratory or cardiac condition that may be worsened by opiates.
- •The subject has developed any allergy to the product excipients, namely, fentanyl, ethanol, menthol, or saccharin.
- •The subject has developed any neurologic or psychiatric disease that, in the opinion of the investigator, would compromise data collection.
- •The subject has begun to abuse alcohol or other substance(s).
- •The subject has hepatic dysfunction as shown by alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) levels elevated more than 5 times the upper limit of normal.
- •The subject has renal dysfunction as shown by creatinine elevated more than 1.5 times the upper limit of normal.
- •The subject has any other clinically significant abnormality in the laboratory tests that, in the opinion of the investigator, will compromise the conduct of the study.
- •The subject has uncontrolled infection.
- •The subject is taking intrathecal or epidural forms of opioids.
- •The subject is taking any prohibited medications as described in the concomitant medications section of the protocol.
研究者
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尚未招募
3 期
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