ISRCTN20173707已完成4 期
Combination pharmacotherapy for the management of pain in fibromyalgia: a double-blind, randomised, placebo-controlled, four-period crossover trial
Queen's University (Canada)0 个研究点目标入组 69 人开始时间: 2011年2月28日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Fibromyalgia according to American College of Rheumatology (ACR) criteria 1990
- •2. Experiencing daily moderate pain (greater than or equal to 4/10) for at least 3 months
- •3. Adults aged 18 to 70 years, either sex
- •4. Patients entering the study on duloxetine, gabapentinoids and other drugs which adversely interact with study drugs (e.g., selective serotonin receptor inhibitors [SSRIs], momanime oxidase inhibitors [MAOIs], tramadol etc.) must be weaned off. Participants taking less than 200 mg morphine equivalents/day are allowed to continue these medications at a steady dose.
- •5. Permitted analgesic medications are non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen (4 g/d) and aspirin (less than or equal to 325 mg/d for cardiac prophylaxis)
- •6. Serum laboratory results obtained at study entry:
- •6.1. Liver function tests: alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 1.2 times upper limit of normal
- •6.2. Creatinine clearance less than 1.5 times upper limit of normal
- •6.3. Negative serum betaHCG for women of childbearing potential
- •7. Adequate birth control for all women of child-bearing potential
- •8. Sufficient cognitive function and English language skills to complete questionnaires and communicate verbally with the nursing staff to permit titration of the study drugs
排除标准
- •1. Presence of a painful condition, including inflammatory rheumatic disease, as severe as (or worse than), but distinct from, their fibromyalgia
- •2. Pregnancy or lactation
- •3. Women of child-bearing potential not using adequate contraceptives
- •4. End-stage kidney or liver disease
- •5. Unstable cardiovascular disease (myocardial infarction [MI] within preceding year, unstable angina or congestive heart failure) or clinically relevant abnormal 12-lead electrocardiogram
- •6. Signs or symptoms of any central neurologic disorder (including seizures)
- •7. Untreated endocrine disorder
- •8. A severe mood disorder as diagnosed by a psychiatrist and/or active suicidal ideation
- •9. Hypersensitivity to any of the study medications
- •10. History of significant abuse of illicit drugs, prescription drugs or alcohol as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV R)
- •11. Patients requiring continued treatment with drugs which adversely interact with study medication (e.g. quinolone antibiotics, warfarin, SSRIs etc.)
- •12. Patients taking more than 200 mg morphine equivalents/day
- •13. Uncontrolled diabetes mellitus
- •14. Uncontrolled hypertension
- •15. Documented human immunodeficiency virus (HIV), hepatitis and other clinically relevant liver dysfunction
- •16. Malignant diseases (including brain tumours)
- •17. Subjects under other investigational studies
- •18. Hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrose isomaltase insufficiency
- •19. Uncontrolled narrow-angle glaucoma
- •20. Continued use of MAOIs, fluvoxamine, selective serotonin reuptake inhibitors (SSRIs) and anticoagulants
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