Effect of Roux-en-Y gstric bypass surgery in morbidly obese patients on Pharmacokinetics of (Acetyl)salicylic acid and Omeprazole. - ERY-PAO

Department of hospital Pharmacy, Medical Centre Haaglanden0 个研究点开始时间: 2013年2月6日最近更新: 2013年4月1日

适应症

试验速览

暂无简介。

•- Male or female aged between 18 and 65 years at the time of informed consent.
•- Written informed consent
•- Scheduled to undergo RYGB surgery and approved to undergo this procedure according to the inclusion criteria of NOK West (Dutch Obesity Clinic West)
•- Ability to swallow whole medication tablets
•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 40
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Ulceration or leakage of the anastomosis post-surgery, to be determined 6 weeks after the RYGB surgery by the surgeon. This is an exclusion criterium for the second testday, to be determined during the study
•- ‘Redo’ patients: patients previously treated for morbid obesity with a gastric sleeve or gastric banding.
•- Contra-indication to use ASA or omeprazole, e.g. known or suspected allergy
•- Present use or use of drugs within 4 times the half-life of that drug before the start of the study that might interfere with the metabolism of the investigational drugs (inducers/inhibitors of CYP2C19)
•- Concurrent disease or increased risk of bleeding which may compromise safety of the administration of the study medication (e.g. Von Willebrands disease) according to the judgement of the investigator.
•- Gastro-intestinal disorders which may impair drug absorption (e.g. Crohn's disease or previous stomach or bowel surgery) according to the judgement of the investigator.
•- Treatment with any unlicensed drug during the previous month.

发起方

Department of hospital Pharmacy, Medical Centre Haaglanden