Comparative Efficacy & Safety Study of Esomeprazole Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With NSAID

May 10, 2010 updated by: AstraZeneca

A Phase III, Multicentre, Randomised, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of Esomeprazole(20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

343

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
      • Kyoto, Japan
        • Research Site
      • Nagano, Japan
        • Research Site
      • Oita, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
      • Saitama, Japan
        • Research Site
      • Shizuoka, Japan
        • Research Site
    • Aichi
      • Chiryu, Aichi, Japan
        • Research Site
      • Seto, Aichi, Japan
        • Research Site
    • Chiba
      • Yotukaido, Chiba, Japan
        • Research Site
    • Fukuoka
      • Mizumaki, Fukuoka, Japan
        • Research Site
    • HYOGOi
      • Akashi, HYOGOi, Japan
        • Research Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Research Site
    • Hyogo
      • Itami, Hyogo, Japan
        • Research Site
      • Koto, Hyogo, Japan
        • Research Site
      • Nishinomiya, Hyogo, Japan
        • Research Site
    • Ibaragi
      • Hitachi, Ibaragi, Japan
        • Research Site
    • Iwate
      • Morioka, Iwate, Japan
        • Research Site
    • Kanagawa
      • Sagamihara, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Kyoto
      • Nagaokakyo, Kyoto, Japan
        • Research Site
    • Nagano
      • Chiisagata, Nagano, Japan
        • Research Site
      • Matsumoto, Nagano, Japan
        • Research Site
    • Nagasaki
      • Sasebo, Nagasaki, Japan
        • Research Site
    • Oita
      • Beppu, Oita, Japan
        • Research Site
    • Okayama
      • Ihara, Okayama, Japan
        • Research Site
    • Osaka
      • Hirakata, Osaka, Japan
        • Research Site
      • Sakai, Osaka, Japan
        • Research Site
      • Suita, Osaka, Japan
        • Research Site
      • Takatsuki, Osaka, Japan
        • Research Site
    • Saitama
      • Kawagoe, Saitama, Japan
        • Research Site
    • Shizuoka
      • Fukuroi, Shizuoka, Japan
        • Research Site
      • Hamamatsu, Shizuoka, Japan
        • Research Site
      • Izunokuni, Shizuoka, Japan
        • Research Site
      • Maikinohara, Shizuoka, Japan
        • Research Site
      • Yaizu, Shizuoka, Japan
        • Research Site
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Research Site
    • Tokyo
      • Chiyoda, Tokyo, Japan
        • Research Site
      • Koto, Tokyo, Japan
        • Research Site
      • Musashimurayama, Tokyo, 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:

  • Medical history of gastric and/or duodenal ulcer
  • A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age

Exclusion Criteria:

  • Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
  • History of esophageal, gastric or duodenal surgery
  • Having severe liver disease or chronic renal disease

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Placebo
Drug: Placebo
once daily oral
Experimental: 2
Esomeprazole 20 mg
Drug: Esomeprazole
20mg once daily oral
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Gastric and/or Duodenal Ulcer Throughout the Treatment Period
Time Frame: each visit up to 24 weeks
The absence of gastric and/or duodenal ulcer throughout the treatment period
each visit up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Gastric and/or Duodenal Ulcer up to 4 Weeks After Treatment
Time Frame: up to 4 weeks
The absence of gastric and/or duodenal ulcer up to 4 weeks after treatment
up to 4 weeks
Absence of Gastric and/or Duodenal Ulcer up to 12 Weeks After Treatment
Time Frame: up to 12 weeks
The absence of gastric and/or duodenal ulcer up to 12 weeks after treatment
up to 12 weeks

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Naotsugu Oyama, AstraZeneca Japan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2007

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 11, 2007

First Submitted That Met QC Criteria

October 11, 2007

First Posted (Estimate)

October 12, 2007

Study Record Updates

Last Update Posted (Estimate)

May 28, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D961HC00001

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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