NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT00206180
Collaborator
(none)
120
39
14
3.1
0.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
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 Start Date
:
Jun 1, 2004
Actual Study Completion Date
:
Aug 1, 2005
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Secondary outcomes and the relationship to pH will also be assessed. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Alabaster | Alabama | United States | |
| 2 | Research Site | Anaheim | California | United States | |
| 3 | Research Site | Dinuba | California | United States | |
| 4 | Research Site | Fresno | California | United States | |
| 5 | Research Site | Orange | California | United States | |
| 6 | Research Site | San Diego | California | United States | |
| 7 | Research Site | Bridgeport | Connecticut | United States | |
| 8 | Research Site | Fort Lauderdale | Florida | United States | |
| 9 | Research Site | Hialeah | Florida | United States | |
| 10 | Research Site | Jacksonville | Florida | United States | |
| 11 | Research Site | Miami | Florida | United States | |
| 12 | Research Site | New Port Richey | Florida | United States | |
| 13 | Research Site | Zephyr Hills | Florida | United States | |
| 14 | Research Site | Decatur | Georgia | United States | |
| 15 | Research Site | Rome | Georgia | United States | |
| 16 | Research Site | Savannah | Georgia | United States | |
| 17 | Research Site | Oakbrook Terrace | Illinois | United States | |
| 18 | Research Site | Urbana | Illinois | United States | |
| 19 | Research Site | Louisville | Kentucky | United States | |
| 20 | Research Site | Covington | Louisiana | United States | |
| 21 | Research Site | Baltimore | Maryland | United States | |
| 22 | Research Site | Chevy Chase | Maryland | United States | |
| 23 | Research Site | Kalamazoo | Michigan | United States | |
| 24 | Research Site | Troy | Michigan | United States | |
| 25 | Research Site | Egg Harbor Township | New Jersey | United States | |
| 26 | Research Site | Passaic | New Jersey | United States | |
| 27 | Research Site | Brooklyn | New York | United States | |
| 28 | Research Site | New York | New York | United States | |
| 29 | Research Site | Chapel Hill | North Carolina | United States | |
| 30 | Research Site | Jacksonville | North Carolina | United States | |
| 31 | Research Site | Duncansville | Pennsylvania | United States | |
| 32 | Research Site | Pittsburgh | Pennsylvania | United States | |
| 33 | Research Site | N Providence | Rhode Island | United States | |
| 34 | Research Site | Knoxville | Tennessee | United States | |
| 35 | Research Site | Dallas | Texas | United States | |
| 36 | Research Site | Ogden | Utah | United States | |
| 37 | Research Site | Bellevue | Washington | United States | |
| 38 | Research Site | Spokane | Washington | United States | |
| 39 | Research Site | Milwaukee | Wisconsin | United States |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Nexium Medical Science Director, MD, AstraZeneca
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00206180
Other Study ID Numbers:
- D9612L00062
First Posted:
Sep 21, 2005
Last Update Posted:
Mar 26, 2009
Last Verified:
Mar 1, 2009
Additional relevant MeSH terms: