NCT00325676

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 639 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Pantoprazole

Timeline

• Start date: 2006-06-01
• First posted: 2006-05-15
• Last updated: 2012-05-07

Locations

45 sites across 4 countries: Brazil, Germany, Poland, South Africa