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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00206024
Other study ID # D9612L00064
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated November 18, 2010
Start date November 2004
Est. completion date July 2005

Study information

Verified date November 2010
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Esomeprazole magnesium (Nexium)


Locations

Country Name City State
Puerto Rico Research Site Ponce
United States Research Site Anaheim California
United States Research Site Annapolis Maryland
United States Research Site Asheville North Carolina
United States Research Site Atlanta Georgia
United States Research Site Attleboro Massachusetts
United States Research Site Baltimore Maryland
United States Research Site Chicago Illinois
United States Research Site Christiansburg Virginia
United States Research Site DeLand Florida
United States Research Site Elkin North Carolina
United States Research Site Guthrie Oklahoma
United States Research Site Hackensack New Jersey
United States Research Site Hollywood Maryland
United States Research Site Knoxville Tennessee
United States Research Site Miami Florida
United States Research Site New Orleans Louisiana
United States Research Site New Smyrna Beach Florida
United States Research Site Orange California
United States Research Site Philadelphia Pennsylvania
United States Research Site Rochester New York
United States Research Site San Diego California
United States Research Site Tampa Florida
United States Research Site Tucson Arizona
United States Research Site Vineland New Jersey
United States Research Site Washington District of Columbia
United States Research Site Zephyrhills Florida

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

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