RANDOMISED, CONTROLLED CLINICAL STUDY REGARDING THE FEASIBILITY OFCONVERTING OPIATE DEPENDENTS FROM METHADONE SUBSTITUTES TO SLOWRELEASE MORPHINE SULPHATE (SEVRE-LONG®)

Mundipharma Medical Company, Basel0 个研究点目标入组 200 人开始时间: 2009年3月11日最近更新: 2012年5月1日

试验速览

暂无简介。

•Minimum age: 18 years
•Fixed abode
•At least 26 weeks of treatment (up to date) receiving a minimum dose of 50 mg methadone or
•= 25 mg/day levomethadone at inclusion. Patients on levomethadone must be informed and
•agree to be switched to methadone
•Mature and capable of acting responsibly, in possession of all mental faculties
•Contraception (non-hormonal, hormonal) by women of child-bearing age
•No intention of reducing the substitute medication during the trial
•Acceptance of the trials rules and regulations
•Acceptance to participate in the study.
•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

•(Desired) pregnancy during the trial
•Grave or acute somatic illnesses (e.g. cardio-vascular, serious kidney or liver affection (ALAT
•or ASAT > 5x augmented)) or other somatic disorder
•If suffering from severe unstable mental health problems
•If MAO-Inhibitors or are being taken
•Known hypersensitivity to Morphine
•Paralytic ileus
•Baseline QTc interval greater than 450 msec
•Long QT Syndrome
•Patients who have participated in another clinical research study involving a new chemical entity within 3 months of study entry
•Patients with pending imprisonment at the time of inclusion.

发起方

Mundipharma Medical Company, Basel