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Profi-Study: Pantoprazole for Symptom Reduction in Hospitalized GERD Patients
NCT00326027Phase 3
Key facts
- Status
- Completed
- Start
- Oct 2006
- Primary completion
- Jul 2007
- Countries
- 1
- Sponsor
- Nycomed
- Modality
- Small Molecules
- Drugs
- pantoprazole
- Conditions
- gastroesophageal reflux disease (GERD)non-erosive reflux disease (NERD)
01
Overview
Phase 3, randomised trial of pantoprazole in gastroesophageal reflux disease (GERD) and non-erosive reflux disease (NERD) (2 arms), sponsored by Nycomed. Primary endpoint: Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI at 1 day. Started Oct 2006; status: completed.
02
Design
2 arms- Study design
- Randomized
Pantoprazole 20 mg
Pantoprazole 20 mg once daily
Pantoprazole 40 mg
Pantoprazole 40 mg once daily
03
Who it enrols
Inpatients with symptomatic NERD or GERD (LA Grade A-D). Excludes patients with ZE syndrome, prior acid-lowering surgery, strictures, Barrett's esophagus, or acute peptic ulcer.
04
Endpoints
Primary
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI
Secondary
Symptom reduction from reflux disease related symptoms as measured by the questionnaire ReQuest™-GI
Symptom relief rates as measured by ReQuest™
Safety
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