Status:
COMPLETED
Determination of the Minimal Clinically Important Difference After Treatment With Pantoprazole in Patients With Symptoms of Acid Reflux (Gastroesophageal Reflux Disease) (BY1023/M3-340)
Lead Sponsor:
Takeda
Conditions:
Gastroesophageal Reflux
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Gastroesophageal reflux disease (GERD) is a medical condition affecting the stomach and esophagus. GERD occurs when the lower esophageal sphincter does not close properly and stomach contents leaks ba...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- In general good health other than gastroesophageal reflux disease (GERD)
- History of GERD-related symptoms for at least 6 months prior to inclusion into the study
- Endoscopically confirmed gastroesophageal reflux disease
- Main exclusion criteria:
- Acute peptic ulcer and/or ulcer complications
- Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors on more than 3 consecutive days within the previous 28 days; except regular intake of acetylsalicylic acid in dosages up to 163 mg/day
- Intake of Proton Pump Inhibitors and Histamine 2-receptor antagonists within the previous 14 days
- Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents
- Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT00246909
Start Date
November 1 2005
End Date
November 1 2006
Last Update
May 7 2012
Active Locations (51)
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1
Altana Pharma/Nycomed
Alabaster, Alabama, United States, 35007
2
Altana Pharma/Nycomed
Huntsville, Alabama, United States, 35801
3
Altana Pharma/Nycomed
Mesa, Arizona, United States, 85213
4
Altana Pharma/Nycomed
Tucson, Arizona, United States, 85723