Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent GERD
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heartburn; Gastroesophageal Reflux Disease
Intervention: Esomeprazole Magnesium (Drug); Lansoprazole (Drug)
Phase: Phase 4
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
A double-blind study comparing Esomeprazole Magnesium 40 mg once daily and Lansoprazole 30 mg
twice daily to control the symptoms in patients with gastroesophageal reflux disease (GERD)
with continued heartburn symptoms with a course of therapy of 30 mg twice daily
Official title: A Multi-Centred, Phase IV, Post-Marketing, Prospective, Randomized, Double-Blind Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease While on 30mg Once Daily Lansoprazole Therapy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Primary outcome: To compare the clinical efficacy of esomeprazole magnesium 40mg once daily versus lansoprazole 30 mg twice daily in symptom control of heartburn in subjects with heartburn symptoms resistant to 30 mg once daily therapy of lansoprazole.
To compare efficacy of esomeprazole magnesium 40mg daily vs lansoprazole 30 mg twice daily in symptom control of acid regurgitation, epigastric pain, and night-time heartburn in subjects with GERD symptoms resistant to 30 mg daily therapy of lansoprazole
To evaluate the use of supplementary antacids (as heartburn rescue therapy) in subjects treated with esomeprazole magnesium 40 mg once daily versus lansoprazole 30 mg twice daily
To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily.
Minimum age: 18 Years.
Maximum age: N/A.
- Subjects must have reported history of heartburn symptoms whilst on lansoprazole 30 mg
twice daily during the 30 days prior to screening.
- Subjects must have a minimal cumulative heartburn score of at least 4 for a minimum of
14 days, where zero = none, one = mild, two = moderate, three = severe.
- subjects history of esophageal ulcers, esophageal strictures, esophageal neoplasms,
gastric or duodenal ulcers, or any other significant gastric or esophageal pathology
judged to be clinically significant by the investigator.
- Subjects with persistent heartburn symptoms while on lansoprazole 30 mg twice daily
for a period of > 6 months
- Subjects with a history of severe hepatic insufficiency (specifically, Childs-Pugh
Class C liver disease) that may adversely affect the metabolism abd pharmacokinetics
of esomeprazole and/or lansoprazole.
Locations and Contacts
Starting date: June 2002
Ending date: May 2003
Last updated: March 11, 2008