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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00868296 |
The purpose of this study is to provide additional information on safety and tolerability after multiple does of pantoprazole. Patients eligible are who successfully completed the 3001B3-331 or 3001B3-333 studies.
Condition | Intervention | Phase |
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Gastroesophageal Reflux |
Drug: pantoprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Muliticenter, Open Label Safety Study of 2 Doses of Pantoprazole Sodium Enteric-Coated Spheroid Suspension in Infants Aged Less Than 12 Months With Presumed GERD |
Enrollment: | 56 |
Study Start Date: | March 2006 |
Study Completion Date: | March 2008 |
Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Medical Monitor | Wyeth |
Principal Investigator: | Trial Manager | For Belgium, trials-BEL@wyeth.com |
Principal Investigator: | Trial Manager | For Germany, medinfoDEU@wyeth.com |
Principal Investigator: | Trial Manager | For Netherlands, trials-NL@wyeth.com |
Principal Investigator: | Trial Manager | For Poland, WPWZMED@wyeth.com |
Principal Investigator: | Trial Manager | For South Africa, ZAFinfo@wyeth.com |
Principal Investigator: | Trial Manager | For Australia, medinfo@wyeth.com |
Principal Investigator: | Trial Manager | For France, infomedfrance@wyeth.com |
Principal Investigator: | Trial Manager | For Italy, descresg@wyeth.com |
Principal Investigator: | Trial Manager | For Switzerland, med@wyeth.com |
Responsible Party: | Wyeth Research ( Gail Comer/ Medical Monitor ) |
Study ID Numbers: | 3001B3-335 |
Study First Received: | March 20, 2009 |
Last Updated: | March 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00868296 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Safety |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Pantoprazole Esophageal Diseases Gastroesophageal Reflux |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Gastrointestinal Diseases Therapeutic Uses Pantoprazole |
Anti-Ulcer Agents Gastrointestinal Agents Esophageal Diseases Gastroesophageal Reflux Pharmacologic Actions |