drugset / Trial / NCT00336219

Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

NCT00336219

Phase 3 Completed 628 enrolled Takeda
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.

Timeline

Start
2006-08
Primary completion
2006-11
Completion
2007-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pantoprazole Other / unclassified 40 mg