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Comparison of the Classical Healing Concept With the Complete Remission Concept After Treatment With Pantoprazole in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) (BY1023/M3-342)

NCT00325676 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 639

Last updated 2012-05-07

No results posted yet for this study

Summary

The aim of this study is to evaluate the complete remission rates, endoscopic relapses, study discontinuation rates, and quality of life parameters in patients with erosive GERD. The study duration consists of a treatment period up to 16 weeks according to the classical healing concept or the complete remission concept. During this period, the patients will receive pantoprazole (tablet) at one dose level once daily. The following observational phase lasts up to 6 months. The study will provide further data on efficacy, safety, and tolerability of pantoprazole.

Conditions

  • Gastroesophageal Reflux Disease

Interventions

DRUG

Pantoprazole

Sponsors & Collaborators

Principal Investigators

  • Werner Janssen, MD · 23569 Lübeck, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30

Countries

  • Brazil
  • Germany
  • Poland
  • South Africa

Study Locations

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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 NCT00325676 on ClinicalTrials.gov