EUCTR2009-011774-15-NL进行中（未招募）1 期
Effects of opioid analgesics on driving ability of pain patients[Untersuchung zur Fahrsicherheit von Schmerzpatienten]
Federal Highway Research Institute / Bundesanstalt für Straßenwesen (BASt)0 个研究点目标入组 47 人开始时间: 2009年10月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
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) Written informed consent.
- •2) Age: = 30 = 65: as far as possible three groups are built consisting of 10 persons each: 30-39, 40-49, 50-65.
- •3) Stable social background
- •4) Body weight within 16-30 according to body mass index (BMI)
- •5) Normal blood pressure and normal heart rate at rest
- •6) Vision normal or corrected to normal
- •7) Valid driver’s license for passenger cars
- •8) Kilometres travelled per year: at least 2.000 km per year during preceding 12 month
- •9) Driving on a regular basis: at least once per week
- •10) Ability to drive a passenger car with manual transmission
- •11) Chronic non-cancer pain responsive to opioid analgesics
- •12) Treatment for at least four weeks with
- •transdermal Fentanyl (e.g. Durogesic Smat®) or
- •transdermal Buprenorphine (e.g. Transtec®) or
- •retarded Oxycodone (e.g. Oxygesic®)
- •13) No dose change within the preceding 14 days
- •14) Dosage at least at
- •12 µg/h transdermal Fentanyl
- •35µg/h transdermal Buprenorphine
- •2x5mg Oxycodone.
- •15) Co-medication with NSAID and/or anticonvulsants and/or antidepressants on a stable dose within the preceding 14 days
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Subjects who fail to meet any of the inclusion criteria
- •2) Persons who are imprisoned or are detained in a health mental institution by court or official order
- •3) Malignant disease
- •4) Severe disabilities that are expected to interfere with computerized testing or car driving
- •5) Women who are pregnant or breast feeding or women of child-bearing potential who are not using a highly effective contraception method with a pearl-index <=1.
- •6) Expected inability to drive the experimental car or to complete computerized testing or endangerment of being overstrained during the driving test or during computerized testing according to the estimation of the physician accomplishing the medical check up.
- •7) Psychological or psychiatric disorders or severe physical disorders (history or current evidence of severe physical or mental disorders, serious gastrointestinal, hepatic, renal, cardiovascular or neurological disorders or severe allergies) that may interfere with participation in computerized testing or driving test
- •8) Subjects with alcohol or drug abuse or dependency
- •9) Unwillingness or inability to abstain from consumption of alcohol, psychoactive medication or drugs within 24 hours prior to the assessment day (urine drug screening, alcohol breath analyzer)
- •10) Excessive smokers (more than 20 cigarettes a day) or excessive drinkers (more than 28 glasses of alcohol containing beverages per week)
- •11) Regular intake of Benzodiazepines (= 4 times per week)
- •12) Intake of Benzodiazepines within 2 days before assessment days
- •13) Regular intake of barbiturates (> 3 times per week) as well as intake of barbiturates within 2 days before the assessment days
- •14) Daily intake of antidepressants in higher dosage (Amitryptilin > 75mg, Doxepin > 75mg, Imipramin > 75mg, Trazodon > 100mg, Sertralin > 50mg, Fluoxetin > 20mg, Fluvoxamin >75mg, Duloxetin > 120mg, Venlafaxin > 225mg, Citalopram > 10mg)
- •15) Daily intake of anticonvulsant in higher dosage (Carbamazepin > 1200mg, Oxcarbazepin >1800mg, Gabapentin >2400mg, Pregabalin >600mg)
- •16) Intake of MAO inhibitors
- •17) Regular intake of un-retarded opioids oder intake of un-retarded opioids within 2 days prior to assessment days
- •18) Regular intake of antihistamines
- •19) Inability to communicate meaningfully with the study staff (insufficient language skills)
- •20) Treatment with the combination of naloxone and Oxycodone (e.g. Targin®)
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