Symptom Adapted Therapy in GERD Patients

NCT00343161 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 441

Last updated 2011-01-24

No results posted yet for this study

Summary

The purpose of the study is to determine whether a maintenance treatment over 12 weeks with esomeprazole 20 mg daily will sufficiently give control over GERD symptoms and how it compares either with an on-demand therapy with esomeprazole 20 mg or an as needed therapy (wait and see regimen) with rescue medication only (antacid), following a 4-weeks acute treatment phase with either esomeprazole 20 mg or esomeprazole 40 mg.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

esomeprazole

DRUG

Gelusil-Lac (Aluminum hydroxide gel,magnesium trisilicate)

Sponsors & Collaborators

Principal Investigators

  • Michael Höcker, MD · AstraZeneca Germany

  • Joachim Labenz, MD · Evan. Jung-Stilling-Krankenhaus, Siegen, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-08-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00343161 on ClinicalTrials.gov