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)

CONFIRM - Confirmation of Superiority of Complete Remission Concept Versus Classical Healing Concept for Treatment of Patients With Erosive GERD

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00325676

Enrollment

639

Registered

2006-05-15

Start date

2006-06-30

Completion date

Unknown

Last updated

2012-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disease

Keywords

GERD, Pantoprazole, Complete Remission

Brief 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.

Interventions

DRUGPantoprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Main Inclusion Criteria: * Written informed consent * Endoscopically confirmed GERD (Los Angeles classification A-D) * Patients whose compliance is expected to be high with respect to the completion of the questionnaires Main

Exclusion criteria

* Other gastrointestinal diseases * Severe concomitant diseases * Proton pump inhibitors (PPIs) during last 14 days before start * H2 receptor antagonists, prokinetics during last 7 days before study start * Helicobacter pylori (H. pylori) eradication during last 28 days before study start

Design outcomes

Primary

Measure	Time frame
time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms	—

Secondary

Measure	Time frame
further efficacy criteria	—
safety	—

Countries

Brazil, Germany, Poland, South Africa

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026