Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00410592
First received: December 12, 2006
Last updated: March 10, 2009
Last verified: March 2009
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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 | Intervention | Phase |
|---|---|---|
|
Gastroesophageal Reflux Disease |
Drug: Esomeprazole 40mg Drug: Pantoprazole 40mg Drug: Lansoprazole 30mg |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Drug Information available for:
Omeprazole
Omeprazole magnesium
Pantoprazole
Lansoprazole
Esomeprazole
Dexlansoprazole
Pantoprazole sodium
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
Further study details as provided by AstraZeneca:
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.
Secondary Outcome Measures:
- Compare nocturnal intragastric pH in Hispanic patients with GERD
- Compare integrated acidity (IGA) using 24-hour monitoring period among Hispanic patients with GERD
- Assess the short-term safety and tolerability of PPIs being studied in Hispanic patients
| Estimated Enrollment: | 90 |
| Study Start Date: | October 2006 |
| Study Completion Date: | May 2007 |
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410592
Locations
| United States, California | |
| Research Site | |
| Anaheim, California, United States | |
| Research Site | |
| Orange, California, United States | |
| Research Site | |
| San Diego, California, United States | |
| United States, Florida | |
| Research Site | |
| Miami, Florida, United States | |
| United States, Illinois | |
| Research Site | |
| Chicago, Illinois, United States | |
| United States, North Carolina | |
| Research SIte | |
| Chapel Hill, North Carolina, United States | |
| United States, Texas | |
| Research Site | |
| Houston, Texas, United States | |
| Puerto Rico | |
| Research Site | |
| San Juan, Puerto Rico | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Marta Illueca, MD | AstraZeneca |
| Study Chair: | Kathryn Collison | AstraZeneca |
More Information
No publications provided by AstraZeneca
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00410592 History of Changes |
| Other Study ID Numbers: | D9612L00106 |
| Study First Received: | December 12, 2006 |
| Last Updated: | March 10, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
GERD acid reflux heartburn PPI Hispanic |
Additional relevant MeSH terms:
|
Gastroesophageal Reflux Esophageal Motility Disorders Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Omeprazole Lansoprazole Pantoprazole |
Anti-Ulcer Agents Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Infective Agents Proton Pump Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013