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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00206180
Other study ID # D9612L00062
Secondary ID
Status Completed
Phase Phase 4
First received September 15, 2005
Last updated March 25, 2009
Start date June 2004
Est. completion date August 2005

Study information

Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind


Intervention

Drug:
esomeprazole magnesium (oral medication)


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

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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