Study Evaluating Pantoprazole in Adolescents With GERD
Overview[ - collapse ][ - ]
| Purpose | 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 | Gastroesophageal Reflux |
| Intervention | Drug: pantoprazole |
| Phase | Phase 3 |
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier | NCT00367614 |
| First Received | August 21, 2006 |
| Last Updated | December 7, 2007 |
| Last verified | December 2007 |
Tracking Information[ + expand ][ + ]
| First Received Date | August 21, 2006 |
|---|---|
| Last Updated Date | December 7, 2007 |
| Start Date | January 2007 |
| Estimated Primary Completion Date | August 2007 |
| Current Primary Outcome Measures | Characterization of the PK profile of single and multiple doses of pantoprazole. |
| Current Secondary Outcome Measures | Assess the safety and tolerability of pantoprazole. |
Descriptive Information[ + expand ][ + ]
| Brief Title | Study Evaluating Pantoprazole in Adolescents With GERD |
|---|---|
| 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. |
| Brief Summary | 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). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastroesophageal Reflux |
| Intervention | Drug: pantoprazole |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 20 |
| Estimated Completion Date | August 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - 12-16 years old - clinical diagnosis of GERD - ability to swallow tablets Exclusion Criteria: - GI or malabsorption disorders - chronic use of warfarin - positive pregnancy test |
| Gender | Both |
| Ages | 12 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00367614 |
|---|---|
| Other Study ID Numbers | 3001A3-337 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer |
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer |
| Verification Date | December 2007 |