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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00195208 |
The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux Esophagitis |
Drug: Pantoprazole for approximately 9 weeks |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study |
Official Title: | A Randomized, 2-Period, Crossover, Pharmacodynamic Comparability Study Comparing A Pantoprazole Spheroid Formulation to the Currently Marketed Tablet Formulation in Subjects With GERD and a History of Erosive Esophagitis. |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Orange, California, United States, 92869 | |
San Diego, California, United States, 92103 | |
Anaheim, California, United States, 92801 | |
Los Angeles, California, United States, 90073 | |
United States, Florida | |
Miami, Florida, United States, 33173 | |
United States, Oklahoma | |
Oklahoma City, Oklahoma, United States, 73104 | |
Oklahoma City, Oklahoma, United States, 73112 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104 | |
Philadelphia, Pennsylvania, United States, 19140 |
Study Director: | Medical Monitor | Wyeth |
Study ID Numbers: | 3001B1-332 |
Study First Received: | September 12, 2005 |
Last Updated: | May 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00195208 |
Health Authority: | United States: Food and Drug Administration |
Gastroesophageal Reflux Disease (GERD) |
Deglutition Disorders Esophageal Motility Disorders Esophagitis Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Pantoprazole Esophageal Diseases Gastroenteritis Gastroesophageal Reflux |
Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |