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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00637845
First received: March 11, 2008
Last updated: January 20, 2011
Last verified: January 2011

March 11, 2008
January 20, 2011
June 2002
February 2003   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00637845 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ]
  • To assess tolerability of esomeprazole magnesium 40 mg twice daily versus lansoprazole 30 mg twice daily. [ Time Frame: Ongoing Adverse event collection ]
Same as current
Not Provided
Not Provided
 
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 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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Heartburn
  • Gastroesophageal Reflux Disease
  • Drug: Esomeprazole Magnesium
    40mg once daily
    Other Name: Nexium
  • Drug: Lansoprazole
    30mg twice daily
    Other Name: Prevacid
  • Experimental: 1
    40mg once daily
    Intervention: Drug: Esomeprazole Magnesium
  • Active Comparator: 2
    30mg twice daily
    Intervention: Drug: Lansoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
248
February 2003
February 2003   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00637845
311, D9612L00055
Not Provided
Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
AstraZeneca
Not Provided
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
AstraZeneca
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP