The effect of a gastric bypass surgery on the absorption of acetylsalicylic acid and omeprazole after ingestion.
- Conditions
- Roux-en-Y gastric bypass (RYGB) surgery is a successful treatment for morbid obesity. In this procedure, a small gastric pouch is created. The duodenum is bypassed by connecting the jejunum to this stomach pouch. The duodenum is then connected to a lower part of the jejunum to ensure passage of bile salts and pancreatic enzymes.Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2012-005387-10-NL
- Lead Sponsor
- Department of hospital Pharmacy, Medical Centre Haaglanden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method