Gastroesophageal Reflux Disease Clinical Trial
Official title:
A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily
| Verified date | March 2009 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | August 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years - Patients must have moderate to severe erosive esophagitis Exclusion Criteria: - Significant gastrointestinal bleeding - Severe heart, lung, liver or kidney disease - Esophagitis not related to acid reflux |
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind
| Country | Name | City | State |
|---|---|---|---|
| United States | Research Site | Alabaster | Alabama |
| United States | Research Site | Anaheim | California |
| United States | Research Site | Baltimore | Maryland |
| United States | Research Site | Bellevue | Washington |
| United States | Research Site | Bridgeport | Connecticut |
| United States | Research Site | Brooklyn | New York |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Chevy Chase | Maryland |
| United States | Research Site | Covington | Louisiana |
| United States | Research Site | Dallas | Texas |
| United States | Research Site | Decatur | Georgia |
| United States | Research Site | Dinuba | California |
| United States | Research Site | Duncansville | Pennsylvania |
| United States | Research Site | Egg Harbor Township | New Jersey |
| United States | Research Site | Fort Lauderdale | Florida |
| United States | Research Site | Fresno | California |
| United States | Research Site | Hialeah | Florida |
| United States | Research Site | Jacksonville | Florida |
| United States | Research Site | Jacksonville | North Carolina |
| United States | Research Site | Kalamazoo | Michigan |
| United States | Research Site | Knoxville | Tennessee |
| United States | Research Site | Louisville | Kentucky |
| United States | Research Site | Miami | Florida |
| United States | Research Site | Milwaukee | Wisconsin |
| United States | Research Site | N Providence | Rhode Island |
| United States | Research Site | New Port Richey | Florida |
| United States | Research Site | New York | New York |
| United States | Research Site | Oakbrook Terrace | Illinois |
| United States | Research Site | Ogden | Utah |
| United States | Research Site | Orange | California |
| United States | Research Site | Passaic | New Jersey |
| United States | Research Site | Pittsburgh | Pennsylvania |
| United States | Research Site | Rome | Georgia |
| United States | Research Site | San Diego | California |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Spokane | Washington |
| United States | Research Site | Troy | Michigan |
| United States | Research Site | Urbana | Illinois |
| United States | Research Site | Zephyr Hills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium. | |||
| Secondary | Secondary outcomes and the relationship to pH will also be assessed. |
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