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CompletedNCT00637845Updated Jan 21, 2011

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

A Phase 4 interventional study of Esomeprazole Magnesium and Lansoprazole in Heartburn and Gastroesophageal Reflux Disease, sponsored by AstraZeneca. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-21.

Sponsored by AstraZeneca · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Heartburn
  • Gastroesophageal Reflux Disease

Keywords

  • Nexium
  • Esomeprazole Magnesium
  • Gastroesophageal Reflux Disease
  • Heartburn
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 248 is above the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
248 participants (actual)

Study arms

  • Experimental
    1

    40mg once daily

    Drug: Esomeprazole Magnesium

  • Active comparator
    2

    30mg twice daily

    Drug: Lansoprazole

Interventions

  • DrugEsomeprazole Magnesium

    40mg once daily

    Also known as: Nexium

  • DrugLansoprazole

    30mg twice daily

    Also known as: Prevacid

06

What researchers measure

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.

    Time frame: Heartburn symptoms collected on diary card daily

Secondary outcomes

  1. 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

    Time frame: Heartburn symptoms collected on diary card daily

  2. 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

    Time frame: Heartburn symptoms collected on diary card daily

  3. To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily.

    Time frame: Ongoing Adverse event collection

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00637845
Lead sponsor
AstraZeneca
First posted
Mar 18, 2008
Start date
Jun 2002
Primary completion
Feb 2003
Completion
Feb 2003
Last update
Jan 21, 2011

Study contacts

Paula Fernstrom
study director · Nexium Global Product Director, AstraZeneca
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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