Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04423588
Status:
WITHDRAWN
Last Update Posted:
2022-02-01
First Post:
2020-02-07
Brief Title:
Dexlansoprazole Absorption and Marginal Ulceration After Gastric Bypass
Sponsor:
Spital Limmattal Schlieren
Organization:
Spital Limmattal Schlieren
Study Overview
Official Title:
Prospective Monocentric Study of Dexlansoprazole Absorption Preoperative and 6 and 12 Months After Proximal Roux-en-Y Gastric Bypass Surgery and of the Incidence of Marginal Ulcers 6 and 12 Months After Surgery
Status:
WITHDRAWN
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In Switzerland the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery Since marginal ulceration is a known complication after this Operation a Proton pump Inhibitor PPI prophylaxis is prescribed postoperatively Bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs There are only very little data on the pharmacokinetics of PPIs following PRYGB
The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population
The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population
Detailed Description:
This prospective monocentric study includes 30 patients undergoing a proximal Roux-en-Y gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant dexlansoprazole The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole Peripheral blood samples from the study participants are obtained at fixed time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6 months after surgery The incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery The surgery the PPI prophylaxis and the upper endoscopy 12 months post-surgery arent for study purpose Data collection is made by measuring serum drug concentration patient questionnaires pill count and upper endoscopy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None