EUCTR2004-004908-21-DK进行中（未招募）1 期
A Phase II, double-blind, randomized, cross-over, international,multicentre study to evaluate the analgesic efficacy of 3 weeks oraladministration of AZD4282 300 mg b.i.d. compared with placebo inpostherpetic neuralgia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.
- •2. Be able to understand and comply with the requirements of the study.
- •3. Female or male subjects 18-80 years of age.
- •4. Female subjects must be post-menopausal by at least 2 years or surgically sterile.
- •5. Diagnosis of postherpetic neuralgia, i.e. history of acute herpes zoster with pain
- •persisting in the affected skin area at least 6 months after resolution of skin rash.
- •6. Mean pain intensity =40 on 100 mm VAS during baseline week, based on
- •recordings of average pain intensity last 24 hours.
- •All inclusion criteria, except no 6, must be fulfilled at visit 1. All inclusion criteria must be
- •fulfilled at visit 2.
- •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 that may confound assessment of pain attributed to postherpetic
- •neuralgia, as judged by the investigator.
- •2.Subjects that have been treated with neurolytic procedures (chemical or surgical
- •nerve lesioning) for postherpetic neuralgia.
- •3.Severe, unstable or insufficiently treated hypertension, cardiovascular,
- •cerebrovascular or peripheral vascular disease, as judged by the investigator.
- •4.Diabetes Mellitus requiring pharmacological treatment (insulin, antidiabetics), or,
- •with any organ complication.
- •5.Diagnosis or history of any severe neurological disease (e.g. epilepsy, MS,
- •Parkinson´s disease, neurodegenerative disease), as judged by the investigator.
- •6.History of alcohol or drug abuse within the last 2 years.
- •7.Any other serious or unstable medical or psychiatric condition, as judged by the
- •investigator (e.g. HIV, organ transplanted subjects, malignancy treatment).
- •8.S-Creatinine above 106 µmol/L. Any AZ standard laboratory test value outside AZ
- •extended reference range (S-Bilirubin, S-ASAT, S-ALAT, S-Alkaline Phosphatase,
- •S-Creatinine, S-Albumin, S-Potassium, S-Calcium, S-Sodium, B-Hemoglobin, (B-Hb),
- •B-Leucocyte Particle Concentration (B-LPC; including B-differential count:
- •lymphocytes, monocytes, neutrophiles, eosinophiles, and basophiles, B-Platelet
- •Particle count and dipstick test for U-Glucose, U-Protein, U-Hemoglobin (U-Hb),
- •U-Leucocytes.
- •9.Treatment with opioids (other than tramadol as rescue medication), cannabinoids,
- •any antidepressants, anticonvulsants, or antiarrythmics from 3 weeks before visit 1
- •(screening visit) until the last visit.
- •10.Treatment with topical local anaesthetics, topical capsaicin, acupuncture, nerve
- •blockade or nerve stimulation treatments.
- •11.Treatment with acidic albumin bound drugs with a low safety margin, e.g. warfarin,
- •cloxacillin, methotrexate, chloral hydrate, etacrynic acid.
- •12.Treatment with potentially nephrotoxic drugs, e.g. acetylsalicylic acid exceeding
- •160 mg daily dose, NSAIDs, COX-2-inhibitors, aminoglycosides, cefalosporins,
- •sulfonamides, trimetoprim, lithium, cyclosporine.
- •13.Treatment with substrates of CYP3A4 with a low safety margin, e.g.
- •benzodiazepines, statines, calcium-channel blockers, sildenafil, macrolide
- •antibiotics, ergot alkaloids, quinine, cisapride, astemizole, terfenadine, eplerenone.
- •14.Treatment with NMDA-antagonists, e.g. ketamine, dextromethorphan, memantine.
- •15.Treatment with probenecide.
- •16.Treatment with herbal remedies that may interfere with the study interpretation, as judged by the investigator.
- •17.Intake of energy drinks containing taurine or glucuronolactone.
- •18.Donation of plasma from 2 weeks before visit 1 (screening visit), or donation of
- •blood from 3 months before visit 1, and throughout the study.
- •19.A history of symptoms of hypersensitivity reactions (such as asthma, rhinitis or
- •urticaria) or contra-indications to paracetamol/acetaminophen or tramadol.
- •20.Participation in another investigational drug study within 30 days prior to visit 1.
- •21.Previous enrolment in the present study or any other study on AZD4282.
- •All exclusion criteria, except no 8, must not be fulfilled at visit 1. None of the exclusion
- •criteria must be fulfilled at visit 2.
研究者
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