EUCTR2016-001143-40-FR进行中（未招募）1 期
ong-term effects of Roux-en-Y Gastric Bypass on morphine exposure after oral administration of immediate release morphine, in comparison with subjects without surgery - OBEMO 1 Extension
Therapeutic Research Unit0 个研究点开始时间: 2016年9月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
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
- •RYGB Group (n=12)
- •-Subjects who undergone RYGB for at least 48 months included in OBEMO1 ans OBEMO2
- •- Stable weight since almost one year (or weight loss below 10kg over the last year)
- •Control group (n=12)
- •-Volunteers subjects, matched for age, sex, and Body mass index
- •-No history of bariatric surgery
- •Same characteristics
- •-Subjects volunteers for the study
- •-Age 20-70 years
- •-Written consent
- •- Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) < 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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •- Individuals under the protection of a conservaor, curatorship, guardianship
- •-Uncontrolles seizures
- •-Known allergy to morphine or naloxone
- •-Patients not affiliated to the french social security system.
- •-Subjects yet recruited in a study with remuneration
- •-Abnormalities in liver function (TP<70%and/or ASAT>5N and/or ALAT>5N) and/or in renal function (creatinine clearance MDRD<60ml/min)
- •- Respiratory insufficiency defined by an oxigen saturation below 90%.
- •-Pregnancy and breastfeeding
- •-Use of drugs contra-indicated or not advised with morphine:
- •Agonists-antagonists Opioids (buprenorphine, nalbuphine, pentazocine), Naltrexone
- •Alcohol intake> 30g by day
- •Cough medicine morphine-like (dextromethorphan, noscapin, pholcodin)
- •Codeine, éthylmorphine
- •Other morphine agonists (alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidin, remifentanil, sufentanil, tramadol)
- •Barbiturates, Benzodiazepines.
- •Rifampicin
- •- Drug addiction score according to criteria of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) = 2
- •Morphine/ opiate addiction or abuse, or history of morphine/ opiate addiction or abuse
研究者
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