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Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00644735
First received: March 18, 2008
Last updated: March 25, 2009
Last verified: March 2009
History of Changes
  Purpose

A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).


Condition Intervention Phase
Erosive Esophagitis
 Drug: Esomeprazole
Drug: Lansoprazole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE). [ Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 ]

Secondary Outcome Measures:
  • To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE. [ Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 ]
  • The assessment of symptoms in the two treatment groups after 1, 3 and 6 months. [ Time Frame: patients will undergo an endoscopy at Months 3 and 6 ]
  • To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE. [ Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 ]

Estimated Enrollment: 750
Study Start Date: December 2002
Study Completion Date: January 2004
Primary Completion Date: January 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nexium
 Drug: Esomeprazole
Other Name: Nexium
Active Comparator: 2
Prevacid
 Drug: Lansoprazole
Other Name: Prevacid

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline
  • Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study.

Exclusion Criteria:

  • Any signs of gastrointestinal bleeding at the time of the starting the study.
  • Any previous gastric or esophageal surgery.
  • Various gastrointestinal diseases as listed in the protocol.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644735

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
  More Information

No publications provided

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
ClinicalTrials.gov Identifier: NCT00644735     History of Changes
Other Study ID Numbers: 325, D9612L00048
Study First Received: March 18, 2008
Last Updated: March 25, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Erosive Esophagitis
Nexium
Esomeprazole
Lansoprazole
Heartburn

Additional relevant MeSH terms:
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Omeprazole
Lansoprazole
 Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 16, 2013