Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent GERD

Condition(s) targeted: Heartburn; Gastroesophageal Reflux Disease

Intervention: Esomeprazole Magnesium (Drug); Lansoprazole (Drug)

Phase: Phase 4

Status: Completed

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 Lansoprazole.

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.

Secondary outcome:

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. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Starting date: June 2002
Ending date: May 2003
Last updated: March 11, 2008