The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation.
- GERD and a history of Erosive Esophagitis documented by endoscopy
- H. pylori negative
- Gastrointestinal conditions such as esophageal stricture, esophageal varices, previous
vagotomy
- Achlorhydria
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing a Pantoprazole Formulation to the Currently Marketed Tablet for GERD and Erosive Esophagitis | |||
| Official Title ICMJE | 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. | |||
| Brief Summary | The purpose of this study is to demonstrate pharmacodynamic comparability between the pantoprazole spheroid formulation and the marketed tablet formulation. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 3 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: Pantoprazole for approximately 9 weeks | |||
| Study Arms ICMJE | Not Provided | |||
| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 97 | |||
| Original Enrollment ICMJE | 65 | |||
| Actual Study Completion Date ICMJE | November 2005 | |||
| Actual Primary Completion Date | November 2005 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00195208 | |||
| Other Study ID Numbers ICMJE | 3001B1-332 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | February 2013 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
