Status:
COMPLETED
Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)
Lead Sponsor:
Takeda
Conditions:
GERD
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT00336219
Start Date
August 1 2006
End Date
April 1 2007
Last Update
May 7 2012
Active Locations (40)
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1
Altana Pharma/Nycomed
Bondi Junction, Australia, NSW 2022
2
Altana Pharma/Nycomed
Box Hill, Victoria, Australia, 3128
3
Altana Pharma/Nycomed
New South Wales, Australia, 2138
4
Altana Pharma/Nycomed
South Australia, Australia, 5000