A Phase IIa randomised, double-blind, placebo controlled, parallel group, multicentre study evaluating the efficacy, safety, tolerability and pharmacokinetics of AZD1386 after 3 weeks of treatment in patients with Posttraumatic Neuralgia (PTN) and Postherpetic Neuralgia (PHN)

AstraZeneca AB0 个研究点目标入组 90 人开始时间: 2009年6月26日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: AstraZeneca AB
入组人数: 90

研究概览入排标准研究者记录与标识符相似试验

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

•1.Provision of informed consent prior to any study specific procedures
•2.Male or female patients =18 and <80 years of age. Females must not be of childbearing potential or must have a highly effective contraceptive method for the last 3 months, as described in Appendix D.
•Women not being of childbearing potential are defined as women who are permanently or surgically sterilized or postmenopausal. Permanent sterilisation includes hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy but excludes bilateral tubal occlusion. Postmenopausal women are defined as over 50 years old and have been amenorrheic for 12 months or more, following cessation of all exogenous hormonal treatments, or over 57 years old.
•3.Patients with painful symptoms due to neuropathic pain for a period of three months to five years. At examination patients have to have mechanical hypersensitivity (allodynia and/or punctate hyperalgesia).
•Definition of allodynia: A painful sensation to a non-painful stimulus.
•Definition of hyperalgesia: An exaggerated painful sensation to a painful stimulus.
•Patients will be eligible for inclusion if all criteria for one of the following disease-specific criteria are met:
•-PTN: Pain directly related to peripheral nerve injury caused by trauma or surgery and not associated with ongoing infection. Examples include but are not limited to post-inguinal herniorrhaphy syndrome, post-thoracotomy syndrome, and traumatic mononeuropathies.
•-PHN: A history of Herpes Zoster (Shingles) with pain persisting in the affected skin area at least three months after resolution of the skin rash.
•4.A pain intensity (7 days recall) of =4 to =9 on NRS (0-10) is required for enrolment.
•At randomisation (Visit 3) a 4-day mean baseline pain intensity (12 h recall twice daily, morning and evening) of =4 to =9 is required. The patient is also required to complete at least 3 out of 4 morning and evening baseline NRS assessments (evening of Day – 4 until morning of Day 1) to be eligible.
•5.Patients must be both willing and able to comply with and understand the study requirements.
•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

•1.Other pain conditions that may confound assessment of neuropathic pain, as judged by the investigator
•2.Central neuropathic pain conditions such as associated with stroke, multiple sclerosis, or spinal cord injury
•3.Any prior treatment of neuropathic pain with neurolytic therapy, intrathecal pump, spinal cord stimulator or neurosurgery
•4.History, and/or presence, of somatic disease/condition, which may interfere with the objectives of the study as judged by the investigator
•5.Diagnosis of any severe neurological disease (e.g. epilepsy, MS, Parkinson´s disease, neurodegenerative disease) as judged by the investigator
•6.Malabsorption, gastrointestinal disorder or surgery leading to impaired drug absorption
•7.History of malignancy, treated or untreated, within the past 5 years, with the exception of successfully treated basal cell or squamous cell carcinoma of the skin
•8.Risk factors for ventricular fibrillation (e.g. family history of Short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first-degree relatives
•9.QTcF interval <350 msec or >450 msec at enrolment
•10.A recent history (in the past 3 months) suggestive of alcohol or drug abuse or dependence, including overuse/abuse of narcotics for management of pain
•11.Enrolment laboratory value for ALT, AST >2 times the upper limit of normal range
•12.Positive test result for hepatitis B surfactant antigen (HbsAg) or hepatitis C antibody
•13.Known or suspected human immunodeficiency virus (HIV) infection, as judged by the investigator
•14.Clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator
•15.Use of any prohibited medication at V2
•16.History of treatment failure with = 3 adequate trials of medication used to treat neuropathic pain. Failure could be insufficient efficacy or discontinuation due to side effects.
•17.History of significant psychiatric disease/disorder that could preclude reliable participation in the study in the judgement of the investigator. Subjects with a diagnosis of depression who are in remission for at least 12 weeks before enrolment with or without stable selective serotonin reuptake inhibitor (SSRI) treatment are allowed in the study.
•18.Patients involved in processes regarding monetary compensation due to the condition under study (e.g. insurance issues).
•19.Breast-feeding women
•20.Positive pregnancy test
•21.Donation of plasma within the two weeks prior to the enrolment visit and/or donation of blood within the three months prior to the enrolment visit and during the study
•22.Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
•23.Participation in other clinical trial, use of any investigational drugs or procedures or use of experimental medications within 30 days prior to the enrolment visit
•24.According to the investigator the patient should not participate in the study
•25.Clinically significant illness within two weeks before the administration of the investigational product, as judged by the investigator
•26.Patients with a cognitive disorder which would impair cooperation with study procedures, as judged by the investigator
•27.Previous randomisation in the present study
•28.A history of symptoms of hypersensitivity reactions (such as asthma, rhinitis or urticaria) or contraindications to paracetamol/acetaminophen
•29.Positive urine drugs of abuse screen including cannabis, cocaine, heroin/m

研究者

发起方

AstraZeneca AB

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