The effect of a gastric bypass surgery on the absorption of acetylsalicylicacid and omeprazole after ingestion.
Recruiting
- Conditions
- Roux-en-Y gastric bypass surgery (RYGB)
- Registration Number
- NL-OMON26757
- Lead Sponsor
- Department of Hospital PharmacyMedical Centre Haaglanden
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1. Male or female aged between 18 and 65 years at the time of informed consent;
2. Written informed consent;
Exclusion Criteria
1. 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;
2. Contra-indication to use ASA or omeprazole, e.g. known or suspected allergy;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary study parameters are drug 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.
- Secondary Outcome Measures
Name Time Method o secondary study parameters are defined.