Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Heartburn Clinical Trial

Official title:

A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206024
• Other study ID #: D9612L00064
• 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
• 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

• Heartburn

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.