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 个研究点目标入组 40 人开始时间: 2005年12月14日最近更新: 2014年10月7日

适应症

试验速览

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•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.

发起方

Bart Morlion