Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Overview[ - collapse ][ - ]
| Purpose | This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD. |
|---|---|
| Condition | Gastroesophageal Reflux Disease |
| Intervention | Drug: Esomeprazole 40mg Drug: Pantoprazole 40mg Drug: Lansoprazole 30mg |
| Phase | Phase 4 |
| Sponsor | AstraZeneca |
| Responsible Party | AstraZeneca |
| ClinicalTrials.gov Identifier | NCT00410592 |
| First Received | December 12, 2006 |
| Last Updated | March 10, 2009 |
| Last verified | March 2009 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 12, 2006 |
|---|---|
| Last Updated Date | March 10, 2009 |
| Start Date | October 2006 |
| Estimated Primary Completion Date | May 2007 |
| Current Primary Outcome Measures | To compare the pharmacodynamic efficacy in controlling intragastric pH following administration of esomeprazole 40 mg, lansoprazole 30 mg, and pantoprazole 40 mg taken orally, once daily in Hispanic patients with symptomatic GERD. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD |
|---|---|
| Official Title | A Randomized, Open-Label, Comparative 3-Way Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40 mg, Lansoprazole 30 mg, and Pantoprazole 40 mg at Steady State in Hispanic Patients With Symptomatic GERD |
| Brief Summary | This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Condition | Gastroesophageal Reflux Disease |
| Intervention | Drug: Esomeprazole 40mg Drug: Pantoprazole 40mg Drug: Lansoprazole 30mg |
| Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 90 |
| Estimated Completion Date | May 2007 |
| Estimated Primary Completion Date | Not Provided |
| Eligibility Criteria | Inclusion Criteria: - Signed informed consent - Males and females ages 18-69 who are of Hispanic origin - Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months Exclusion Criteria: - Female patients who are pregnant or breastfeeding - Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix - Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Puerto Rico |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT00410592 |
|---|---|
| Other Study ID Numbers | D9612L00106 |
| Has Data Monitoring Committee | Not Provided |
| Information Provided By | AstraZeneca |
| Study Sponsor | AstraZeneca |
| Collaborators | Not Provided |
| Investigators | Study Director: Marta Illueca, MD AstraZenecaStudy Chair: Kathryn Collison AstraZeneca |
| Verification Date | March 2009 |
Locations[ + expand ][ + ]
| Research Site | Anaheim, California, United States |
|---|---|
| Research Site | Orange, California, United States |
| Research Site | San Diego, California, United States |
| Research Site | Miami, Florida, United States |
| Research Site | Chicago, Illinois, United States |
| Research SIte | Chapel Hill, North Carolina, United States |
| Research Site | Houston, Texas, United States |
| Research Site | San Juan, Puerto Rico |