EUCTR2005-001165-33-BEActive, not recruitingNot Applicable
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
Bart Morlion0 sites40 target enrollmentStarted: December 14, 2005Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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