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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00634114 |
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Date of registration:
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04/03/2008 |
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Primary sponsor: |
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Public title:
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Reflux Esophagitis Phase III Study (Maintenance Treatment)
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Scientific title:
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A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg Once Daily Oral Administration With Omeprazole 10 mg and Esomeprazole 10 mg Once Daily Oral Administration in Maintenance Treatment in Patients With Healed Reflux Esophagitis |
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Date of first enrolment:
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January 2008 |
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Target sample size:
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540 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00634114 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Japan
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Contacts
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Name:
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Maotsugu Oyama, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with healed Reflux Esophagitis verified by EGD in the preceding study
(D961HC00002)
- Patients with endoscopically verified healed Reflux Esophagitis by EGD receiving
general treatment with PPI
Exclusion Criteria:
- Gastric or duodenal ulcer verified by EGD within 12 weeks before randomisation.
- Use of any PPI from 14 days before EGD performed at the screening visit to the day of
randomisation.
Age minimum:
20 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Reflux Esophagitis
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Intervention(s)
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Drug: Esomeprazole
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Drug: Omeprazole
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Primary Outcome(s)
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Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
[Time Frame: Up to 24 weeks]
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Secondary Outcome(s)
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Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
[Time Frame: Up to 12 weeks]
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Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
[Time Frame: up to 4 weeks]
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Secondary ID(s)
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D961HC00006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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