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CompletedNCT00461604NEXBACUpdated May 20, 2008

High Dosage Esomeprazole and Baclofen for Therapy of Gastroesophageal Reflux Disease

An observational study in Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole, sponsored by Technical University of Munich. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-05-20.

Sponsored by Technical University of Munich · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 70 Years
Sex
All
01

Study 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-metry/impedance 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-metry/impedance monitoring was performed. In case of pathological findings additional baclofen was administered to the therapeutic regime. After 3 months another ph-metry/impedance 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.

02

Conditions studied

  • Patients With Persistent Objectified Gastroesophageal Reflux and Reflux-Associated Symptoms Despite PPI-Therapy With 40mg Esomeprazole

Keywords

  • gastroesophageal reflux disease
  • baclofen
  • impedance
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's planned enrollment of 40 is below the median of 180 across 298 observational studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age between 18-70 years
  • informed consent
  • patients with persistent reflux-associated symptoms despite PPI-therapy

Exclusion criteria

Exclusion Criteria:

  • epilepsy
  • synthetic liver diseases
  • renal failure
  • disability to understand informed consent
05

Study design

Time perspective
Prospective
Enrollment
40 participants (estimated)
06

Study locations

1 site
  • Technical University of Munich
    Munich, Bavaria 81675, Germany
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00461604
Lead sponsor
Technical University of Munich
First posted
Apr 18, 2007
Start date
Oct 2006
Primary completion
May 2008
Completion
May 2008
Last update
May 20, 2008

Study contacts

Alexander Meining, MD
principal investigator · Technische University Munich

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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