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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

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ClinicalTrials.gov Identifier: NCT00644735
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : March 26, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
Erosive Esophagitis Drug: Esomeprazole Drug: Lansoprazole Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : December 2002
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
Nexium
Drug: Esomeprazole
Other Name: Nexium

Active Comparator: 2
Prevacid
Drug: Lansoprazole
Other Name: Prevacid




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]
  3. 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 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644735


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

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, Astra Zeneca
ClinicalTrials.gov Identifier: NCT00644735     History of Changes
Other Study ID Numbers: 325
D9612L00048
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

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
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action