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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Esomeprazole
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014