Status:
COMPLETED
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)
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 co...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
639 Patients enrolled
Trial Details
Trial ID
NCT00325676
Start Date
June 1 2006
Last Update
May 7 2012
Active Locations (45)
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1
Altana Pharma/Nycomed
Belo Horizonte-MG, Brazil, 30150270
2
Altana Pharma/Nycomed
Blumenau - SC, Brazil, 89010906
3
Altana Pharma/Nycomed
Botucatu - SP, Brazil, 18610970
4
Altana Pharma/Nycomed
Campinas - Sao Paulo, Brazil, 13070040