A randomised, double-blind, parallel group trial to assess the variability and treatment effect size for a Neuropathic Pain offset design

Pfizer Ltd0 个研究点目标入组 40 人开始时间: 2005年3月9日最近更新: 2019年12月16日

试验速览

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•- Male or female, aged 18 and over
•- Female patients must be non-pregnant and non-lactating, and be postmenopausal, surgically sterilized, or using an appropriate method of contraception (hormonal or intrauterine device), throughout and four weeks after completion of the study.
•- Patients with neuropathic pain, defined as pain initiated or caused by a primary lesion or dysfunction in the nervous system (IASP 1994 definition). If pain is of mixed origin then it must have a predominantly neuropathic component as defined by a total score of ³ 4 on the DN4 questionnaire (Bouhassira et al., 2004b).
•- Patients who are known to respond to gabapentin at a daily dose of 1200, 1500, or 1800 mg, which has not been adjusted within 4 weeks of screening. A responder is defined by the following:
•. a documented reduction of global pain of ³ 50% following the start of gabapentin treatment. If documentary evidence is not available then a Patient’s Global Impression of Change (PGIC) of much improved” or very much improved” following the start of gabapentin treatment is acceptable provided the patient has been on gabapentin for £ 6 months, and
•a global pain score £ 4 on an 11-point scale at screening.
•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

•- Patients with trigeminal neuralgia- Patients with pain of mixed origin (eg, chronic lower back pain, head pain, visceral pain, etc) unless there is a documented predominant neuropathic component responsive to gabapentin.
•- Patients with any co-existing pain which he/she cannot differentiate from the neuropathic pain.
•- Patients with any evidence of clinically significant renal impairment.
•- Patients with any clinically significant abnormality following review of pre-study laboratory data and full physical examination.
•- History of chronic hepatitis B or C, acute hepatitis A, B, or C within the past 3 months, or HIV infection.
•- Participation in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
•- Patients who have a history of alcohol or illicit drug abuse in the past 2 years.
•- Use of prohibited medications as defined, unless the appropriate washout period has been observed.
•- Clinically significant or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise participation in the study.

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