Study of the Concentrations of Long Acting Morphine After Oral Absorption in Subjects Who Underwent Gastric Bypass (OBEMO 2)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration.
研究概览
简要总结
The purpose of this study is to determine whether sustained release morphine pharmacokinetics parameters in patients undergone roux-en-y gastric bypass (RYGB) differ from subjects who did not. Our hypothesis is that exposure is comparable. Indeed, in the Study OBEMO (Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass; NCT00943969) the investigators observed changes in pharmacokinetics parameters for immediate release morphine, probably due to an earlier absorption of the morphine, in agreement with the expected clinical effect of this formulation.
详细描述
This is an open label study with two arms: patients undergone roux-en-y gastric bypass and volunteers who did not matched by sex, age and Body Mass Index (BMI). In the pharmacokinetic visit the subject takes an oral administration of sustained release morphine, 30 mg, then 11 samples are collected during 12 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •RYGB Group (n=12) :
- •Subjects who undergone RYGB for at least 24 months
- •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 20-65 years
- •Written consent
排除标准
- •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 Prothrombin ratio <70% and/ or aspartate transaminase > 5 times the usual values and/ or alanine aminotransferase >5 times the usual values and/ or in renal function (creatinine clearance Modification of Diet in Renal Disease (MDRD) < 60ml/ min
- •Respiratory insufficiency defined by an oximetry 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, noscapine, pholcodine )
- •Codeine, ethylmorphine
- •Other morphine agonist ( alfentanil, codeine, dextromoramide, dextropropoxyphene, dihydrocodeine, fentanyl, oxycodone, pethidin, phenoperidine, remifentanil, sufentanil, tramadol )
- •Barbiturates, benzodiazepines
- •Rifampicin
研究组 & 干预措施
Subjects Roux-en-Y-gastric bypass (RYGB)
Sustained release morphine sulfate, 30 mg
干预措施: Sustained release morphine sulfate, 30 mg (Drug)
Control volunteers matched with RYGB
Sustained release morphine sulfate, 30 mg
干预措施: Sustained release morphine sulfate, 30 mg (Drug)
结局指标
主要结局
Morphine area under the curve (AUC0-inf) after its oral administration according to the morphine concentration.
时间窗: During the study visit: morphine concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after its oral administration
次要结局
- Observed Volume of distribution [Vd / F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide(During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration)
- Area under ther curve [AUC] of morphine-3-glucuronide, morphine-6-glucuronide(During the study visit: concentration at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration)
- Observed clearance [Cl/F] of morphine, morphine-3-glucuronide, morphine-6-glucuronide(During the study visit: concentrations at time 0,5h; 1h; 1,5h; 2h; 2,5h; 3h; 4h; 5h; 6h; 8h; 12h after morphine oral administration)
- Plasma Half-Life [T1 /2] of morphine, morphine-3-glucuronide, morphine-6-glucuronide(During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration)
- Maximum plasma concentration [Cmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide(During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration)
- Time of the maximum plasma concentration [Tmax] of morphine, morphine-3-glucuronide, morphine-6-glucuronide(During the study visit: concentrations at time hour 0,5 ; hour 1; hour 1,5 ; hour 2; hour2,5; hour3; hour 4; hour 5; hour 6; hour 8; hour 12 after morphine oral administration)
研究者
Célia Lloret-Linares, MD PhD
MD, PhD
Hopital Lariboisière