EFFICACY AND SAFETY OF ESLICARBAZEPINE ACETATE (BIA 2 093)AS THERAPY FOR PATIENTS WITH POST-HERPETIC NEURALGIA:A DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMISED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTRE CLINICAL TRIA

BIAL - Portela & Ca, S.A.0 个研究点目标入组 540 人开始时间: 2007年8月31日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Inclusion criteria at screening:
•Written informed consent to participate in the study
•Men and women aged 18 years or older
•Previous diagnosis of herpes zoster
•Diagnosis of postherpetic neuralgia and neuropathic pain present for more than 3 months after healing of the herpes zoster skin rash
•Cooperation and willingness to complete all aspects of the study
•Inclusion criteria at randomisation:
•Completion of at least 4 daily diaries during the week preceding randomisation
•A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Pain of other origin that might confound the assessment of neuropathic pain of postherpetic origin
•Active herpes zoster lesion or dermatitis of any origin at the affected site
•Subjects who had neurological ablation by block or neurosurgical intervention for control of pain
•Significant or unstable medical or psychiatric disorders
•Drug or alcohol abuse in the preceding 2 years
•Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening
•Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of the normal, white blood cell count (WBC) <2,500 cells/mm3)
•Previous participation in any study with eslicarbazepine acetate
•Pregnancy or breast feeding
•History of hypersensitivity to the investigational products or to drugs with a similar chemical structure
•History of non-compliance
•Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol
•Participation in a clinical study within 3 months prior to screening
•Any clinical significant concomitant condition which might influence the assessments or conduct of the trial.

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