A prospective, open randomized, parallel group trial to compare the efficacy and safety of transdermal buprenorphine (Transtec) with gabapentin (Neurontin) in patients with neuropatic pain syndromes - NA
- Conditions
- europathic pain
- Registration Number
- EUCTR2005-001165-33-BE
- Lead Sponsor
- Bart Morlion
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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):
- Secondary Outcome Measures
Name Time Method