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Reflux Esophagitis Phase III Study (Initial Treatment)

Primary Purpose

Reflux Esophagitis

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Omeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reflux Esophagitis focused on measuring Reflux Esophagitis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation

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 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Esomeprazole 20mg

Esomeprazole 40mg

Omeprazole 20mg

Outcomes

Primary Outcome Measures

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

Secondary Outcome Measures

Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).

Full Information

First Posted
March 4, 2008
Last Updated
December 2, 2010
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00633932
Brief Title
Reflux Esophagitis Phase III Study (Initial Treatment)
Official Title
A Multicentre, Randomised, Double-blind, Parallel-group, Comparative Study to Compare the Efficacy and Safety of Esomeprazole 20 mg and 40 mg Once Daily Oral Administration With Omeprazole 20 mg Once Daily Oral Administration in Patients With Reflux Esophagitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to evaluate the efficacy of esomeprazole 20 mg once daily and 40 mg once daily for 8 weeks on healing of Reflux Esophagitis in patients with reflux esophagitis in comparison with omeprazole 20 mg once daily by assessment of presence/absence of Reflux Esophagitis at Week 8 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
602 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Esomeprazole 20mg
Arm Title
2
Arm Type
Experimental
Arm Description
Esomeprazole 40mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
Omeprazole 20mg
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
20mg once daily
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Description
40 mg once daily
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Prilosec
Intervention Description
20mg once daily
Primary Outcome Measure Information:
Title
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification".
Description
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification
Description
Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break < 5 mm in length), Grade B (Mucosal break > 5mm), Grade C (Mucosal break continuous between > 2 mucosal folds) and Grade D (Mucosal break >75% of esophageal circumference).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Endoscopically verified Reflux Esophagitis classified into Los Angeles classification Grade A, B, C or D within 1 week before randomisation 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
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Nukaya
State/Province
Fukuoka
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 (Initial Treatment)

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