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 Malignicies - P-AD923-006 extension study

i3 Research0 个研究点目标入组 33 人开始时间: 待定最近更新: 2024年5月13日

研究概览

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•1. subject completed study protocol P-AD923-005
•2. subject met all eligible criteria for protocol P-AD923-005
•3. subject continues to take opioid therapy for chronic cancer pain and continues to require therapy for episodes of BTP, minimun dose of background therapy should be 60 mg/day of morphine or morphine equivalent or 25 µg/hour transdermal fentanyl
•4. if female of chilbearing potential, the subject has a negative urine pregnancy test
•5. subject is able and willing to understand the study and cooperate with the study instructions
•6. subject is able and willing to provide written informed consent
•7. subject has a life expectancy of at least 2 months
•8. subject or his or her caregiver must have easy, reliable access to a telephone

•1. The subject is a female who is pregnant or lactating.
•2. The subject has developed any respiratory or cardiac condition that may be worsened by opiates.
•3. The subject has developed any allergy to the product excipients, namely, fentanyl, ethanol, menthol, or saccharin.
•4. The subject has developed any neurologic or psychiatric disease that, in the opinion of the investigator, would compromise data collection.
•5. The subject has begun to abuse alcohol or other substance(s).
•6. 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.
•7. The subject has renal dysfunction as shown by creatinine elevated more than 1.5 times the upper limit of normal.
•8. 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.
•9. The subject has uncontrolled infection.
•10. The subject is taking intrathecal or epidural forms of opioids.
•11. The subject is taking any prohibited medications as described in the concomitant medications section (Section 6.3).

发起方

i3 Research