Clinical trial NCT00206180: NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Erosive Esophagitis
Reflux Esophagitis
Gastroesophageal Reflux Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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 outcomes:
measure: Secondary outcomes and the relationship to pH will also be assessed.
Other outcomes:
Locations:
city: Alabaster
country: United States
facility: Research Site
state: Alabama
city: Anaheim
country: United States
facility: Research Site
state: California
city: Dinuba
country: United States
facility: Research Site
state: California
city: Fresno
country: United States
facility: Research Site
state: California
city: Orange
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Bridgeport
country: United States
facility: Research Site
state: Connecticut
city: Fort Lauderdale
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: New Port Richey
country: United States
facility: Research Site
state: Florida
city: Zephyr Hills
country: United States
facility: Research Site
state: Florida
city: Decatur
country: United States
facility: Research Site
state: Georgia
city: Rome
country: United States
facility: Research Site
state: Georgia
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Oakbrook Terrace
country: United States
facility: Research Site
state: Illinois
city: Urbana
country: United States
facility: Research Site
state: Illinois
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: Covington
country: United States
facility: Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Chevy Chase
country: United States
facility: Research Site
state: Maryland
city: Kalamazoo
country: United States
facility: Research Site
state: Michigan
city: Troy
country: United States
facility: Research Site
state: Michigan
city: Egg Harbor Township
country: United States
facility: Research Site
state: New Jersey
city: Passaic
country: United States
facility: Research Site
state: New Jersey
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: New York
country: United States
facility: Research Site
state: New York
city: Chapel Hill
country: United States
facility: Research Site
state: North Carolina
city: Jacksonville
country: United States
facility: Research Site
state: North Carolina
city: Duncansville
country: United States
facility: Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Site
state: Pennsylvania
city: N Providence
country: United States
facility: Research Site
state: Rhode Island
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Ogden
country: United States
facility: Research Site
state: Utah
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: AstraZeneca
name: Nexium Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2007 Mar 1;25(5):617-28. doi: 10.1111/j.1365-2036.2006.03235.x.