The effect of Roux-en-Y gastric bypass surgery in morbidly obese patients on Pharmacokinetics of (Acetyl)salicylic acid and Omeprazole.

Completed

• Conditions: gastric bypass surgery; Roux-en-Y gastric bypass surgery; 10017998

• Registration Number: NL-OMON39934
• Lead Sponsor: Medisch Centrum Haaglanden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study parameters are drug blood concentrations on the selected test<br /><br>days and times: 0 (before intake of the drugs), 30 minutes after intake, 1<br /><br>hour, 2 hours and 4 hours after intake. With these concentrations the following<br /><br>pharmacokinetic parameters will be determined: Time to peak concentration<br /><br>(Tmax), peak concentration (Cmax), area under the curve (AUC), and half-life (t<br /><br>*) of salicylic acid and omeprazole. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>No secundary study parameters are defined.</p><br>