Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461604
Status:
COMPLETED
Last Update Posted:
2008-05-20
First Post:
2007-04-16
Brief Title:
High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEXBAC
Brief Summary:
It has been reported that Baclofen is an appropriate tool in the therapeutic management of Gastroesophageal Reflux Disease To objectify gastroesophageal reflux combined pH-metryimpedance monitoring was applied to patients with persistent reflux-associated symptoms despite PPI-therapy 40mg esomeprazole for 2 weeks After provement of pathological findings in the test PPI-dosage was escalated to double standard-dosage for another for weeks In case of persistent symptoms another ph-metryimpedance monitoring was performed In case of pathological findings additional baclofen was administered to the therapeutic regime After 3 months another ph-metryimpedance monitoring was performed At the time point of the tests a questionnaire was completed
Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional baclofen in patients with persistent symptoms and objectified gastroesophageal reflux
Aim of the study was to evaluate the influence of high dosage PPI-therapy and additional baclofen in patients with persistent symptoms and objectified gastroesophageal reflux
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None