Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Phase 4

Completed

• Conditions: Heartburn

• Registration Number: NCT00206024
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study Completion: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-18
• Last Update Posted: 2010-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Relief of heartburn during the 4th week of treatment
Cumulative daily sustained resolution rate through 4 weeks of treatment
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.

Trial Locations

Locations (1)

Research Site; 🇵🇷 Ponce, Puerto Rico