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Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Primary Purpose

Heartburn

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Esomeprazole magnesium (Nexium)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heartburn

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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Outcomes

Primary Outcome Measures

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 Outcome Measures

Relief of heartburn during the 4th week of treatment
Cumulative daily sustained resolution rate through 4 weeks of treatment
Time to first day of the first 7-day period of sustained resolution of heartburn
Time to the first day of the first 7-day period of relief of heartburn
Percentage of subject-reported heartburn-free days through 4 weeks of treatment
Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.

Full Information

First Posted
September 12, 2005
Last Updated
November 18, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00206024
Brief Title
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

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heartburn

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
330 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole magnesium (Nexium)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Relief of heartburn during the 4th week of treatment
Title
Cumulative daily sustained resolution rate through 4 weeks of treatment
Title
Time to first day of the first 7-day period of sustained resolution of heartburn
Title
Time to the first day of the first 7-day period of relief of heartburn
Title
Percentage of subject-reported heartburn-free days through 4 weeks of treatment
Title
Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
Title
Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nexium Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Tucson
State/Province
Arizona
Country
United States
Facility Name
Research Site
City
Anaheim
State/Province
California
Country
United States
Facility Name
Research Site
City
Orange
State/Province
California
Country
United States
Facility Name
Research Site
City
San Diego
State/Province
California
Country
United States
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
Country
United States
Facility Name
Research Site
City
DeLand
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Miami
State/Province
Florida
Country
United States
Facility Name
Research Site
City
New Smyrna Beach
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Tampa
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Zephyrhills
State/Province
Florida
Country
United States
Facility Name
Research Site
City
Atlanta
State/Province
Georgia
Country
United States
Facility Name
Research Site
City
Chicago
State/Province
Illinois
Country
United States
Facility Name
Research Site
City
New Orleans
State/Province
Louisiana
Country
United States
Facility Name
Research Site
City
Annapolis
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Hollywood
State/Province
Maryland
Country
United States
Facility Name
Research Site
City
Attleboro
State/Province
Massachusetts
Country
United States
Facility Name
Research Site
City
Hackensack
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Vineland
State/Province
New Jersey
Country
United States
Facility Name
Research Site
City
Rochester
State/Province
New York
Country
United States
Facility Name
Research Site
City
Asheville
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Elkin
State/Province
North Carolina
Country
United States
Facility Name
Research Site
City
Guthrie
State/Province
Oklahoma
Country
United States
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Research Site
City
Knoxville
State/Province
Tennessee
Country
United States
Facility Name
Research Site
City
Christiansburg
State/Province
Virginia
Country
United States
Facility Name
Research Site
City
Ponce
Country
Puerto Rico

12. IPD Sharing Statement

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Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

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