EUCTR2006-003655-20-GB进行中（未招募）1 期
A double blind, randomised, placebo controlled, parallel group study of Sativex® when added to the existing treatment regimen, in the relief of post-herpetic neuralgia.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 218
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Subjects meeting the following criteria will be considered eligible for this study:·
- •-Subjects aged 18 years or above.·
- •-Diagnosed with post-herpetic neuralgia, of at least three months duration since rash healing, in whom pain is not wholly relieved with their current therapy. ·
- •-Subject has at least moderate pain (due to PHN), which is defined by: NRS pain scores on all of baseline days B2 to B7 have been recorded, via the IVRS, by the subject and sum to at least 24.
- •-Subject fulfils at least one of the two criteria below. Subject must be either:-
- •Currently established on a regular dose of analgesic therapy for their PHN.
- •Previously tried and failed or could not tolerate analgesic therapy for their PHN.
- •-Stable medication regimen for at least 2 weeks prior to study entry, for all medications that may have an affect on neuropathic pain, except paracetamol/ acetaminophen.
- •-Subject is willing to stop taking their own paracetamol/acetaminophen or paracetamol/acetaminophen containing medications and start using study medication paracetamol/acetaminophen as required (prn) for the duration of the study.
- •-Subject is willing to maintain a stable dose of medications that may have an effect on neuropathic pain, other than study medication and paracetamol/acetaminophen, for the duration of the study.
- •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
排除标准
- •The subject may not enter the study if ANY of the following apply:·
- •-Subjects, whose identified pain is likely to be of a nociceptive, musculoskeletal, central neuropathic or psychogenic origin.
- •-Other pain, which is not of a peripheral neuropathic origin thought by the investigator to be of a nature or severity to interfere with the subject’s assessment of PHN.
- •-Currently receiving a prohibited medication and unwilling to stop or comply for the duration of the study.
- •-Currently using or has used recreational cannabis, medicinal cannabis (including Sativex®), or synthetic cannabinoid based medications within 3 months prior to study entry and unwilling to abstain for the duration for the study.
- •-Any known or suspected history of:- or family history of schizophrenia, other psychotic illness- alcohol or substance abuse- epilepsy or recurrent seizures- hypersensitivity to cannabinoids·
- •-Significant cardiac, renal or hepatic impairment.
- •-If female, is pregnant, lactating or planning pregnancy during the course of the study and for three months thereafter.
- •-Travel outside the country of residence planned during the study.
- •-Subjects who have received an Investigational Medicinal Product within the 12 weeks before the screening visit.
研究者
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