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Efficacy of Esomeprazole in Patients With Frequent Heartburn

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Heartburn

Intervention: Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tore Lind, MD, Study Director, Affiliation: AstraZeneca

Summary

This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn

Clinical Details

Official title: A Phase III Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of 14 Day Treatment With Esomeprazole 20 mg Once Daily in Subjects With Frequent Heartburn

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment

Secondary outcome:

Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period

Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo

Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and non-pregnant ,non-lactating females 18 years or older

- Experience heartburn at least 2 days a week

- Having heartburn that has responded to heartburn medication

- Must discontinue any current heartburn medications

Exclusion Criteria:

- Having a history of erosive esophagitis verified by endoscopy

- Having a history of GERD which was diagnosed by a physician

- Inability to take study medication or complete the study and all study procedures

- Subjects that have required more than one 14-day course of PPI treatment within the

past 4 months

Locations and Contacts

Research site, Mobile, Alabama, United States

Research site, San Francisco, California, United States

Research site, Westlake Village, California, United States

Research site, Lexington, Kentucky, United States

Research site, Rochester, New York, United States

Research site, Dakota Dunes, South Dakota, United States

Research site, Nashville, Tennessee, United States

Research site, Austin, Texas, United States

Research site, San Angelo, Texas, United States

Research site, West Jordan, Utah, United States

Additional Information

Starting date: August 2011
Last updated: March 1, 2013

Page last updated: August 23, 2015

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