Clinical trial NCT00206024: Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
Official title: A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heartburn
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
* A history of heartburn for at least 6 months
* A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
* A positive esophageal acid perfusion test
* At least 3 days of 'moderate' severity heartburn over the previous 7 days
* No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization

Exclusion Criteria:

* A history of gastric or esophageal surgery
* H. pylori positive
* A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
* Currently taking higher than the standard approved proton pump inhibitor doses
* Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.

Primary outcomes:
measure: Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
Secondary outcomes:
measure: Relief of heartburn during the 4th week of treatment
measure: Cumulative daily sustained resolution rate through 4 weeks of treatment
measure: Time to first day of the first 7-day period of sustained resolution of heartburn
measure: Time to the first day of the first 7-day period of relief of heartburn
measure: Percentage of subject-reported heartburn-free days through 4 weeks of treatment
measure: Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
measure: Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Anaheim
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: Washington
country: United States
facility: Research Site
state: District of Columbia
city: DeLand
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: New Smyrna Beach
country: United States
facility: Research Site
state: Florida
city: Tampa
country: United States
facility: Research Site
state: Florida
city: Zephyrhills
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Annapolis
country: United States
facility: Research Site
state: Maryland
city: Baltimore
country: United States
facility: Research Site
state: Maryland
city: Hollywood
country: United States
facility: Research Site
state: Maryland
city: Attleboro
country: United States
facility: Research Site
state: Massachusetts
city: Hackensack
country: United States
facility: Research Site
state: New Jersey
city: Vineland
country: United States
facility: Research Site
state: New Jersey
city: Rochester
country: United States
facility: Research Site
state: New York
city: Asheville
country: United States
facility: Research Site
state: North Carolina
city: Elkin
country: United States
facility: Research Site
state: North Carolina
city: Guthrie
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Knoxville
country: United States
facility: Research Site
state: Tennessee
city: Christiansburg
country: United States
facility: Research Site
state: Virginia
city: Ponce
country: Puerto Rico
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Nexium Medical Science Director, MD
role: STUDY_DIRECTOR
References: