A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray)Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy - ND

ARCHIMEDES0 个研究点目标入组 180 人开始时间: 2007年4月30日最近更新: 2012年3月19日

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•Male or female subjects, aged 18 years and older, with a malignancy who are taking regular, 24-hour medication (at least 60 mg oral morphine or equivalent opioid) for his or her underlying persistent cancer pain and who typically have 1 to 4 episodes of BTCP per day are eligible for participation.
•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

•Subjects with uncontrolled or rapidly escalating pain or whose condition is unstable or rapidly deteriorating should not be enrolled. Additionally, subjects with a medical condition (i.e., respiratory, cardiac, hepatic or renal, neurological, psychiatric) that would make them unsuitable for the study should not be enrolled. Subjects with a history of alcohol or substance abuse or who have had radiotherapy within 30 days are not eligible.

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