Neuropathic pain
Conditions
Interventions
Trade Name: Transtec
Product Name: Transtec
Product Code: NA
Pharmaceutical Form: Transdermal patch
INN or Proposed INN: Buprenorphine 35µg/h
CAS Number: 52485-79-7
Concentration type: equal
Concentr
Sponsors
Bart Morlion
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects at least 18 years of age, who have given written informed consent. Subjects with moderate to severe central or peripheral neuropathic pain of at least three months duration. The neuropatic pain is vconfirmed by a score of =12 using the LANSS Pain Scale. At baseline, female subjects of childbearing potential must be using adequate contraception and must have a negative urine pregnancy test. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects wha have been previously on Transtec or gabapentin therapy and who had to stop their treatment due to toerability problems to either drug. Subjects who are pregnant or breastfeeding. Contraindications to Transtec or gabapentin as listed in their respective Summary of Product Characteristics. Subjects with documented or suspected alcohol or drug abuse, or who are suspected of having an addictive personality. Poor physical status or, at the discretion of the investigator, clinical signs that raise concerns about patient's eligibility. Subjects unable to comply with the study assessments and to complete the questionnaires. Patient is currently involved in litigation regarding his pain condition, pending or active disability-compensation claim.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective is to investigate wheter the treatment of neuropathic pain syndromes with buprenorphine shows a comparable efficacy and safety compared to the treatment with gabapentin;Secondary Objective: ;Primary end point(s): | — |
Countries
Belgium
Outcome results
None listed