Back to resultsReflux Esophagitis Phase III Study (Maintenance Treatment)
Primary Purpose
Reflux Esophagitis
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Reflux Esophagitis focused on measuring Reflux Esophagitis
Eligibility Criteria
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.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Esomeprazole and Omeprazole
Esomeprazole
Outcomes
Primary Outcome Measures
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
Secondary Outcome Measures
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00634114
Brief Title
Reflux Esophagitis Phase III Study (Maintenance Treatment)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to evaluate the efficacy of esomeprazole 20 mg once daily for 24 weeks on maintenance of Reflux Esophagitis in patients with healed reflux esophagitis in comparison with omeprazole 10 mg once daily and esomeprazole 10 mg once daily by assessment of presence/absence of recurrence of Reflux Esophagitis throughout the treatment period (from the randomisation to the treatment completion) according to the Los Angeles classification.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reflux Esophagitis
Keywords
Reflux Esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
540 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Esomeprazole and Omeprazole
Arm Title
2
Arm Type
Experimental
Arm Description
Esomeprazole
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
10mg once daily oral administration
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg once daily oral administration
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Prilosec
Intervention Description
10mg once daily oral administration
Primary Outcome Measure Information:
Title
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period.
Description
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated.
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment
Description
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated.
Time Frame
up to 4 weeks
Title
Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment
Description
Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated.
Time Frame
Up to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maotsugu Oyama, MD, PhD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Kashiwa
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Kisarazu
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Koriyama
State/Province
Fukishima
Country
Japan
Facility Name
Research Site
City
Nihonmatsu
State/Province
Fukishima
Country
Japan
Facility Name
Research Site
City
Nishishirakawa
State/Province
Fukishima
Country
Japan
Facility Name
Research Site
City
Fukuoika
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Nukaya
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Fukuoka
State/Province
Fukuolka
Country
Japan
Facility Name
Research Site
City
Koriyama
State/Province
Fukushima
Country
Japan
Facility Name
Research Site
City
Shirakawa
State/Province
Fukushima
Country
Japan
Facility Name
Research Site
City
Sugawa
State/Province
Fukushima
Country
Japan
Facility Name
Research Site
City
Gifu-shi
State/Province
Gifu
Country
Japan
Facility Name
Research Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Yasunaka
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Hitachi
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Mito
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Tsukuba
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Sakaide
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Takamatsu
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Fujisawa
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sagamihara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Shibata
State/Province
Myagi
Country
Japan
Facility Name
Research Site
City
Kiso
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Matsumoto
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Fujiidera
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Toyonaka
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Ohtawara
State/Province
Tochigi
Country
Japan
Facility Name
Research Site
City
Toshima-ku
State/Province
Tokayo
Country
Japan
Facility Name
Research Site
City
Adachi
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Hachioji
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kiyose
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Setagaya
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinagawa
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shimonoseki
State/Province
Yamaguchi
Country
Japan
Facility Name
Research Site
City
Akita
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Shizuoka
Country
Japan
Facility Name
Research Site
City
Tottori
Country
Japan
12. IPD Sharing Statement
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Reflux Esophagitis Phase III Study (Maintenance Treatment)
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