Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-Negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
Information source: ALTANA Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GERD
Intervention: Pantoprazole (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: ALTANA Pharma Official(s) and/or principal investigator(s):
Gerald Holtmann, Prof., Principal Investigator, Affiliation: Department of Gastroenterology, Hepatology and General Medicine, Royal Adelaide Hospital, North Terrace, Adelaide, Australia
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.
Clinical Details
Official title: COMPETITION: Investigation of Clinical Endpoints for Treatment-Induced Gastroesophageal Reflux Disease (GERD) Symptom Changes
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Primary outcome: symptom assessment as measured by ReQuest™ questionnaire and investigator.
Secondary outcome: symptom assessment on days 7, 14, and 28 as measured by ReQuest™ questionnaire and investigatorendoscopic healing after 28 days health-related quality of life after 28 days safety.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Main Inclusion Criteria:
- Written informed consent
- Outpatients
- History of GERD-related symptoms for at least 6 months prior to study inclusion
- Endoscopically confirmed erosive GERD or non-erosive GERD
Main Exclusion Criteria:
- Acute peptic ulcer and/or ulcer complications
- PPIs during last 7 days prior to study start
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2
inhibitors during the last 28 days prior to study start; except regular intake of
acetylsalicylic acid up to a daily dose of 163 mg/day
- Intake of PPIs in combination with antibiotics for eradication of H. pylori
Locations and Contacts
ALTANA Pharma, Cities in Australia, Australia
ALTANA Pharma, Cities in Austria, Austria
ALTANA Pharma, Cities in Germany, Germany
ALTANA Pharma, Cities in Hungary, Hungary
Additional Information
Starting date: August 2006
Last updated: December 15, 2006
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