Pregabalin in patients with central neuropathic pain: a randomised, double-blind, placebo-controlled trial of a flexible-dose regime

Academic Medical Center (AMC) (Netherlands)0 个研究点目标入组 40 人开始时间: 2007年1月22日最近更新: 2015年1月13日

试验速览

暂无简介。

•1. Age 18 years or older
•2. Written informed consent
•3. Patients suffering from severe neuropathic pain caused by lesion or dysfunction in the central nervous system. Neuropathic pain was described by at least one of the following:
•a. burning pain
•b. paroxysmal episodes of shooting pain
•c. pain on light touch
•Additionally, patients had to score above 12 on the Leeds Assessment of Neuropathic Symptoms and Signs questionnaire (LANSS)

•1. Pregnant
•2. Had a history of intolerance, hypersensitivity, or known allergy to pregabalin
•3. Had a known history of significant hepatic, renal, or psychiatric disorder
•4. Had a history of galactose-intolerance, lactase deficiency, or glucose-galactose malabsorption syndrome
•5. Subjects with a calculated creatinine clearance rate below 60 mL/m (estimated from serum creatinine using Cockroft-Gault equation) were specifically excluded
•6. No new analgesic therapies were to be initiated at any time during the trial
•7. Patients who had been exposed previously to gabapentin, regardless of dose and treatment duration, were permitted to enter the study. However, treatment with gabapentin was to be discontinued at least three days before receiving study medication

发起方

Academic Medical Center (AMC) (Netherlands)