lumbalgie
Conditions
Interventions
Trade Name: Temgesic
Product Name: Temgesic
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: Buprenorfine
CAS Number: 52485-79-7
Concentration unit: mg milligram(s)
Concentration number: 0.
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to examine whether an additional analgesic effect can be obtained when oral immediate release morphine is combined with transdermal buprenorphine in the treatment of chronic low back pain;Secondary Objective: ;Primary end point(s): Efficacy: - Pain intensity score (11-point Numeric Rating Scale, NRS) - Oswestry Low Back Pain Disability Questionnaire (ODQ) - Global Patient Satisfaction (5-point verbal rating scale, VRS) - Percentage of responders - Amount of study medication used - Amount of anti-emetic and laxative treatment taken - Percentage of subjects discontinuing due to lack of efficacy Safety: - Percentage of subjects discontinuing due to lack of tolerability - Adverse events | — |
Countries
Belgium
Outcome results
None listed