Open pilot study for the evaluation of the analgesic effect of buprenorphine TDS administered as add-on treatment in patients with chronic neuropathic pain inadequately controlled by conventional therapy. - ND

ISTITUTO NEUROLOGICO CARLO BESTA0 个研究点目标入组 30 人开始时间: 2006年3月14日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•-caucasian male or female out-patients - age 18-75 years inclusive - diagnosis of multiple neuropathy or polyneuropathy - unsatisfactory pain control with pre-trial analgesic medication - stable regimen of pre-trial medication for at least 4 weeks - no conditions known to be contraindications to the use of buprenorphine TDS - no conditions that could hinder the evaluation of therapy efficacy and/or tolerability - written informed consent
•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

•- known hypersensitivity to opioids - opioid dependent patients - patients wha have taken opioids as analgesic - impairmant of respiratory centre and function - patients receiving MAO inhibitors or who have taken MAO inhibitors in the last two weeks - patients with myastenia gravis/delirium tremens/convulsive disorders - incresed intracranial pressure - clinically evident liver function disorders - psychiatric disorders - previous extensive dermal damage in the patch area - pregnant or lactating women - history of alcohol or drug abuse - subjects who have received experimental drugs or have participated in clinical trials within one month prior to screening - employees of the study centre with direct involvement in the study or other studies under the responsibility of the Investigator or study centre

发起方

ISTITUTO NEUROLOGICO CARLO BESTA