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.
- Conditions
- lumbalgie
- Registration Number
- EUCTR2004-002311-91-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method