NCT00637845

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
248

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2002

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2002

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2008

Completed
Last Updated

January 21, 2011

Status Verified

January 1, 2011

Enrollment Period

8 months

First QC Date

March 11, 2008

Last Update Submit

January 20, 2011

Conditions

HeartburnGastroesophageal Reflux Disease

Keywords

NexiumEsomeprazole MagnesiumGastroesophageal Reflux DiseaseHeartburn

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

40mg once daily

Drug: Esomeprazole Magnesium

2

ACTIVE COMPARATOR

30mg twice daily

Drug: Lansoprazole

Interventions

Esomeprazole MagnesiumDRUG

40mg once daily

Also known as: Nexium
1
LansoprazoleDRUG

30mg twice daily

Also known as: Prevacid
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HeartburnGastroesophageal Reflux

Interventions

EsomeprazoleLansoprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Paula Fernstrom

    Nexium Global Product Director, AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 11, 2008

First Posted

March 18, 2008

Study Start

June 1, 2002

Primary Completion

February 1, 2003

Study Completion

February 1, 2003

Last Updated

January 21, 2011

Record last verified: 2011-01