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Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00367614 |
The purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).
Condition | Intervention | Phase |
---|---|---|
Gastroesophageal Reflux |
Drug: pantoprazole |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Multicenter, Randomized, Open-Label, Single And Multiple Dose Study Of The Pharmacokinetics And Safety of Two Dose Levels of Pantoprazole Sodium Tablets In Adolescents Aged 12 Through 16 Years With A Clinical Daignosis Of GERD. |
Ages Eligible for Study: | 12 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 3001A3-337 |
Study First Received: | August 21, 2006 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00367614 |
Health Authority: | United States: Food and Drug Administration |
Adolescents GERD |
Deglutition Disorders Esophageal Motility Disorders Digestive System Diseases Esophageal disorder |
Gastrointestinal Diseases Pantoprazole Esophageal Diseases Gastroesophageal Reflux |
Therapeutic Uses Anti-Ulcer Agents Gastrointestinal Agents Pharmacologic Actions |