A randomised, controlled, 4-week, cross-over study assessing the efficacy and safety of adding oral morphine IR 10mg or sublingual buprenorphine 0.2mg on demand to a treatment with transdermal buprenorphine 35µg/H in non-malignant chronic low back pain.

niversity Hospital Ghent0 个研究点目标入组 40 人开始时间: 2005年12月16日最近更新: 2014年10月7日

适应症

试验速览

暂无简介。

•- Male or female patients of at least 18 years old
•- Suffering from non-malignant chronic low back pain
•- Treated with transdermal buprenorphine 35µg/h for at least 14 days prior to inclusion with clinical improvement and no intolerable side effects
•- Out-patients
•- Written informed consent given
•- At randomisation scoring at least 5 on the NRS
•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

•- Patients suffering from another form of continuous pain that stands out in comparison to the low back pain
•- Participation in another study of investigational drugs or devices parallel to, or less than one month before enrolment, or previous participation in this study
•- Known to or suspected of not being able to comply with the study protocol and the use of the investigational products
•- Poor physical status or, at the discretion of the investigator, clinical signs that raise concerns about patient's eligibility
•- Clinical relevant previous history of opioid intolerance
•- Medical history and/or clinical data indicating malignant disorder
•- Progressive dislocation of vertebral structures, trauma of the spine less than six months prior to study, osteoporotic vertebral fracture less than six weeks prior to study
•- Epidural of infiltrative injection of depot-steroids less than three months prior to the study and during the study period
•- Progressive neurological deficit
•- Fibromyalgia
•- Physiotherapy started less then three weeks prior to study
•- Female subjects of childbearing age not using adequate contraception
•- Pregnant or breastfeeding mothers
•- Alcohol, medication or drug dependency neurotic personality
•- Psychiatric illness, epilepsy or suicide risk
•- Any contra-indication for transdermal buprenorphine (Transtec), morphine IR (MS Direct) or buprenorphine SL (Temgesic) according to the Belgian SmPC

发起方

niversity Hospital Ghent