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.
Conditions
Interventions
Trade Name: Acetylsalicylic acid 'Cardio' 80 mg PCH
Pharmaceutical Form: Dispersible tablet
Trade Name: Losec MUPS 20 mg
Pharmaceutical Form: Gastro-resistant tablet
Sponsors
Department of hospital Pharmacy, Medical Centre Haaglanden
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Literature shows that Roux-en-Y gastric bypass surgery results in problems regarding vitamin and nutrient absorption. In contrast, little research is done on the effect of this procedure on the absorption of oral drugs. Acetylsalicylic acid (ASA) and omeprazole are two commonly prescribed drugs of which the absorption could be altered after RYGB surgery. The main objective of the ERY-PAO trial is to investigate the pharmacokinetics of acetylsalicylic acid (ASA) and omeprazole in morbidly obese subjects before and after RYGB surgery and to compare these data to study if there are differences in pharmacokinetics due to this procedure. ;Secondary Objective: The secondary objective of the ERY-PAO study is to relate the results for omeprazole to CYP2C19 genotype. ;Primary end point(s): The main study parameters are blood concentrations on the selected test days and times: 0 (before intake of the drugs), 30 minutes after intake, 1 hour, 2 hours and 4 hours after intake. With these concentrations the following pharmacokinetic parameters will be determined: Time to peak concentration (Tmax), peak concentration (Cmax), area under the curve (AUC), and half-life (t ½) of salicylic acid and omeprazole. ;Timepoint(s) of evaluation of this end point: The results will be processed and evaluated after completion of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary endpoints are defined;Timepoint(s) of evaluation of this end point: Not applicable as there are no secondary endpoints defined | — |
Countries
Netherlands
Contacts
Public ContactLieke Winkelmolen
Medical Centre Haaglanden
Outcome results
None listed