Sopran - Omeprazole Treatment Versus Surgery

January 21, 2011 updated by: AstraZeneca

Omeprazole Versus Anti-reflux Surgery in the Long-term Management of Peptic Esophagitis - a 10 Year Follow up Study of Patients Previously Studied for 5 Years - A Nordic Multicentre Study

The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

219

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

  • Denmark
      • Aalborg, Denmark
        • Research Site
      • Glostrup, Denmark
        • Research Site
      • Hillerød, Denmark
        • Research Site
      • Kolding, Denmark
        • Research Site
      • Odense, Denmark
        • Research Site
      • Roskilde, Denmark
        • Research Site
  • Finland
      • Kuopio, Finland
        • Research Site
  • Norway
      • Bergen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Örebro, Sweden
        • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Previous inclusion into Astra study I-635 and willing to continue for another 10 years,

Exclusion Criteria:

  • Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or confirmed malignancy; Documented eradication of Helicobacter pylori.

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the safety of omeprazole during long term treatment

Secondary Outcome Measures

Outcome Measure
To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca GI Medical Science Director, MD, AstraZeneca

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

January 1, 1998

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

November 20, 2005

First Submitted That Met QC Criteria

November 21, 2005

First Posted (Estimate)

November 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9584C00004
  • SH OMG 0004

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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