A double-blind, randomised controlled trial of nortriptyline, morphine, and their combination for neuropathic pain

Queen's University (Canada)0 个研究点目标入组 71 人开始时间: 2009年8月3日最近更新: 2016年10月17日

适应症

试验速览

暂无简介。

•1. Neuropathic pain
•2. Daily moderate (greater than or equal to 4/10) pain for at least 3 months
•3. Adults aged 18 to 89 years, either sex
•4. Liver function tests: alanine aminotransferase (ALT), aspartate aminotransferase (AST) less than 1.2 times upper limit of normal
•5. Creatinine less than 1.5 times upper limit of normal
•6. Negative serum beta-human chorionic gonadotrophin (B-HCG) for women of childbearing potential
•7. Adequate birth control for all women of child-bearing potential
•8. Sufficient cognitive function, visual acuity and English language skills to complete questionnaires and communicate verbally with the nursing staff to permit titration of the study drugs

•1. Painful condition as severe as, but distinct from presenting neuropathic pain
•2. Pregnancy or lactation
•3. End-stage kidney or liver disease
•4. Moderate to severe heart disease (myocardial infarction [MI] within preceding year, unstable angina, cardiac conduction defect or congestive heart failure)
•5. Cardiovascular autonomic neuropathy
•6. Postural hypotension greater than 20 mmHg on initial assessment
•7. Males with urinary symptoms attributable to benign prostatic hypertrophy
•8. Patients who live alone and cannot assure daily contact with a friend, family member or caregiver
•9. Angle-closure glaucoma
•10. Ongoing administration of monoamine oxidase inhibitors, serotonin-specific reuptake inhibitors, serotonin-norepinephrine inhibitors
•11. Any serious psychiatric disorder as diagnosed by a psychiatrist (including bipolar disorder)
•12. Seizure disorder
•13. Ongoing administration of anticonvulsants which induce cytochrome P450 enzymes (e.g. carbamazepine, oxcarbazepine, barbiturates and phenytoin) as well as rifampin
•14. Hypersensitivity to, or previous intolerability of, any of the study medications
•15. History of significant abuse of illicit drugs, prescription drugs or alcohol

发起方

Queen's University (Canada)