Status:
COMPLETED
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341)
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux Disease (GERD)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of the present study is to identify factors (such as symptom patterns and symptom scores) that influence the response to treatment with pantoprazole using different evaluation methods (e.g., R...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- Outpatients of at least 18 years (21 years in Argentina)
- Patient considered to have GERD symptoms
- Main
Exclusion
- Acute peptic ulcer and/or ulcer complications
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors (\> 5 days on demand but not more than 3 consecutive days) during the last 28 days before study start (except regular intake of acetylsalicylic acid at a dose up to 163 mg/day)
- Intake of proton pump inhibitors during the last 10 days before study start
- Female patients of childbearing potential not using adequate means of birth control
- Pregnant or breast-feeding females
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00312806
Start Date
May 1 2006
End Date
July 1 2007
Last Update
May 7 2012
Active Locations (186)
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1
Altana Pharma/Nycomed
Buenos Aires, Argentina, 1161
2
Altana Pharma/Nycomed
Buenos Aires, Argentina, 1405
3
Altana Pharma/Nycomed
Buenos Aires, Argentina
4
Altana Pharma/Nycomed
La Plata, Argentina, 1900