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CONFIRM: Pantoprazole in Erosive GERD
NCT00325676Phase 4
Key facts
- Status
- Completed
- Start
- Jun 2006
- Countries
- 4
- Sponsor
- Takeda
- Modality
- Small Molecules
- Drugs
- pantoprazole
- Conditions
- gastroesophageal reflux disease (GERD)
01
Overview
Phase 4, randomised, open-label trial of pantoprazole in gastroesophageal reflux disease (GERD) (2 arms), sponsored by Takeda. Primary endpoint: Time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms at 6 months. Started Jun 2006; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Complete Remission Concept
Pantoprazole treatment until mucosal healing AND symptom relief (max 16 weeks).
Classical Healing Concept
Pantoprazole treatment until mucosal healing only (max 8 weeks).
03
Who it enrols
Adult patients with endoscopically confirmed erosive GERD (Los Angeles classification A-D).
04
Endpoints
Primary
Time to endoscopic relapse and/or unwillingness to continue due to GERD related symptoms
Secondary
Complete remission rate
Endoscopic relapse rate
Study discontinuation rate
Quality of life parameters
Safety and tolerability
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