A Multicentre, Single-Arm, Open-Label Study Of The Repeated Administration Of QUTENZA For The Treatment Of Peripheral Neuropathic Pain - STRIDE

Astellas Pharma Europe Ltd0 个研究点目标入组 300 人2010年8月4日

适应症Peripheral Neuropathic Pain in Postherpetic Neuralgia (PHN), Painful HIV-Associated Neuropathy (HIV-AN), Peripheral Neuropathic Injury (PNI), Idiopathic Small Nerve Neuropathy (ISNN) or other Peripheral Neuropathic Pain (PNP).MedDRA version: 12.1Level: LLTClassification code 10054095Term: Neuropathic pain

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Peripheral Neuropathic Pain in Postherpetic Neuralgia (PHN), Painful HIV-Associated Neuropathy (HIV-AN), Peripheral Neuropathic Injury (PNI), Idiopathic Small Nerve Neuropathy (ISNN) or other Peripheral Neuropathic Pain (PNP).
发起方: Astellas Pharma Europe Ltd
入组人数: 300
状态: 进行中（未招募）
最后更新: 9年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2010年8月4日

结束日期

待定

最后更新

9年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

Astellas Pharma Europe Ltd

入排标准

入选标准

•Common Inclusion Criteria:
•1\.Male or female between 18 and 90 years of age, inclusive.
•2\.Be in good health as determined by the investigator
•3\.Average pain score \>\=4 during screening period (using the average reported pain, from the BPI)
•4\.Intact, non\-iritated, dry skin over the painful area(s) to be treated
•5\.All females of child bearing potential must be willing to use effective methods of birth control during the study and for 30 days following study termination
•6\.Be willing and able to comply with protocol requirements for the duration of study participation
•7\.Subject has given written informed consent
•Population\-specific Inclusion Criteria:
•All subjects must meet one (and only one) of the Population\-Specific Inclusion Criteria for PHN, HIV\-AN, PNI or ISNN or have adequately characterized PNP based on clinical history and examination.

排除标准

•1\.Any prior receipt of QUTENZA open label or blinded study patches
•2\.Use of oral or transdermal opioids exceeding a total daily dose of morphine of 80 mg/day, or equivalent; or any parenteral opioids, regardless of dose, within 7 days preceding the first patch application visit.
•3\.Lack of an effective pain medication strategy for the subject, such as unwillingness to use opioid analgesics during study treatment, or high tolerance to opioids precluding the ability to relieve treatment\-associated discomfort with oxicodone or other analgesic, as judged by the investigator
•4\.Active substance abuse or history of chronic substance abuse within 1 year prior to enrolment or prior chronic substance abuse (including alcoholism) likely to re\-occur during the study period as judged by the investigator
•5\.Use of any topical pain medication, such as non\-steroidal anti\-inflammatory drugs, menthol, methyl salicylate, local anaesthetics, steroids or capsaicin products on the painful areas within 7 days preceding the first patch application visit
•6\.Current use of any investigational agent (excluding antiretrovirals in Phase 3 evaluation to treat HIV infection)
•7\.Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the patient at risk of adverse cardiovascular reactions related to the patch application procedure
•8\.Evidence of another contributing cause for peripheral neuropathy, and/or treatment within 90 days prior to screening visit with any drug that may have contributed to the sensory neuropathy
•9\.Past or current history of Type I or Type II diabetes mellitus
•10\.Current psychotic disorders