Reflux Esophagitis Phase III Study (Initial Treatment)

December 2, 2010 updated by: AstraZeneca

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

602

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan
        • Research Site
      • Fukuoka, Japan
        • Research Site
      • Kyoto, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
      • Tottori, Japan
        • Research Site
    • Chiba
      • Kashiwa, Chiba, Japan
        • Research Site
      • Kisarazu, Chiba, Japan
        • Research Site
    • Fukishima
      • Koriyama, Fukishima, Japan
        • Research Site
      • Nihonmatsu, Fukishima, Japan
        • Research Site
      • Nishishirakawa, Fukishima, Japan
        • Research Site
    • Fukuoka
      • Kurume, Fukuoka, Japan
        • Research Site
      • Nukaya, Fukuoka, Japan
        • Research Site
    • Fukushima
      • Shirakawa, Fukushima, Japan
        • Research Site
      • Sugawa, Fukushima, Japan
        • Research Site
    • Gifu
      • Gifu-shi, Gifu, Japan
        • Research Site
    • Gunma
      • Maebashi, Gunma, Japan
        • Research Site
      • Yasunaka, Gunma, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Ibaraki
      • Hitachi, Ibaraki, Japan
        • Research Site
      • Mito, Ibaraki, Japan
        • Research Site
      • Tsukuba, Ibaraki, Japan
        • Research Site
    • Kagawa
      • Sakaide, Kagawa, Japan
        • Research Site
      • Takamatsu, Kagawa, Japan
        • Research Site
    • Kanagawa
      • Fujisawa, Kanagawa, Japan
        • Research Site
      • Kawasaki, Kanagawa, Japan
        • Research Site
      • Sagamihara, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Myagi
      • Shibata, Myagi, Japan
        • Research Site
    • Nagano
      • Kiso, Nagano, Japan
        • Research Site
      • Matsumoto, Nagano, Japan
        • Research Site
    • Osaka
      • Fujiidera, Osaka, Japan
        • Research Site
      • Toyonaka, Osaka, Japan
        • Research Site
    • Tochigi
      • Ohtawara, Tochigi, Japan
        • Research Site
    • Tokayo
      • Toshima-ku, Tokayo, Japan
        • Research Site
    • Tokyo
      • Adachi, Tokyo, Japan
        • Research Site
      • Hachioji, Tokyo, Japan
        • Research Site
      • Kiyose, Tokyo, Japan
        • Research Site
      • Setagaya, Tokyo, Japan
        • Research Site
      • Shinagawa, Tokyo, Japan
        • Research Site
    • Yamaguchi
      • Shimonoseki, Yamaguchi, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 2
Esomeprazole 40mg
Drug: Esomeprazole
20mg once daily
Other Names:
  • Nexium
Drug: Esomeprazole
40 mg once daily
Other Names:
  • Nexium
EXPERIMENTAL: 1
Esomeprazole 20mg
Drug: Esomeprazole
20mg once daily
Other Names:
  • Nexium
Drug: Esomeprazole
40 mg once daily
Other Names:
  • Nexium
ACTIVE_COMPARATOR: 3
Omeprazole 20mg
Drug: Omeprazole
20mg once daily
Other Names:
  • Prilosec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Time Frame: 8 weeks
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).
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 4 weeks
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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (ESTIMATE)

March 12, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 20, 2010

Last Update Submitted That Met QC Criteria

December 2, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961HC00002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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