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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00637845

Collaborator

(none)

248

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Heartburn Gastroesophageal Reflux Disease	Drug: Esomeprazole Magnesium Drug: Lansoprazole	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

248 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2002

Actual Primary Completion Date :

Feb 1, 2003

Actual Study Completion Date :

Feb 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 40mg once daily	Drug: Esomeprazole Magnesium 40mg once daily Other Names: Nexium
Active Comparator: 2 30mg twice daily	Drug: Lansoprazole 30mg twice daily Other Names: Prevacid

Arm

Intervention/Treatment

Experimental: 1

40mg once daily

Drug: Esomeprazole Magnesium

40mg once daily

Other Names:

Nexium

Active Comparator: 2

30mg twice daily

Drug: Lansoprazole

30mg twice daily

Other Names:

Prevacid

Outcome Measures

Primary Outcome Measures

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. [Heartburn symptoms collected on diary card daily]

Secondary Outcome Measures

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 [Heartburn symptoms collected on diary card daily]
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 [Heartburn symptoms collected on diary card daily]
To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily. [Ongoing Adverse event collection]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.