Esomeprazole in PPI Failures - IMPROVE

March 5, 2009 updated by: AstraZeneca

A Randomised, Open, Phase IV, Parallel Group Multicentre Study to Evaluate a Change of Management in Gastroesophageal Reflux Disease (GERD) Patients by Treatment With Esomeprazole 40 mg or Any Other Proton Pump Inhibitor (PPI), After Initial Treatment Failure, in Ordinary Clinical Practice During 4 Weeks.

The purpose of this study is to assess how PPI treated GERD patients with insufficient symptom control will benefit from a change in management by providing a more efficient acid secretion inhibition during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 4

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

  • Sweden
      • Akersberga, Sweden
        • Research Site
      • Arlov, Sweden
        • Research Site
      • Balsta, Sweden
        • Research Site
      • Boras, Sweden
        • Research Site
      • Bromma, Sweden
        • Research Site
      • Bromolla, Sweden
        • Research Site
      • Dalby, Sweden
        • Research Site
      • Djursholm, Sweden
        • Research Site
      • Enskededalen, Sweden
        • Research Site
      • Goteborg, Sweden
        • Research Site
      • Grangesberg, Sweden
        • Research Site
      • Harnosand, Sweden
        • Research Site
      • Helsingborg, Sweden
        • Research Site
      • Hollviken, Sweden
        • Research Site
      • Jarfalla, Sweden
        • Research Site
      • Kil, Sweden
        • Research Site
      • Knäred, Sweden
        • Research Site
      • Koping, Sweden
        • Research Site
      • Kristinehamn, Sweden
        • Research Site
      • Linkoping, Sweden
        • Research Site
      • Ludvika, Sweden
        • Research Site
      • Lulea, Sweden
        • Research Site
      • Lund, Sweden
        • Research Site
      • Malmo, Sweden
        • Research Site
      • Marsta, Sweden
        • Research Site
      • Nacka, Sweden
        • Research Site
      • Nykoping, Sweden
        • Research Site
      • Orebro, Sweden
        • Research Site
      • Partille, Sweden
        • Research Site
      • Pitea, Sweden
        • Research Site
      • Sandviken, Sweden
        • Research Site
      • Solna, Sweden
        • Research Site
      • Stenstorp, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Sunne, Sweden
        • Research Site
      • Trollhättan, Sweden
        • Research Site
      • Täby, Sweden
        • Research Site
      • Uppsala, Sweden
        • Research Site
      • Vannas, Sweden
        • Research Site
      • Varberg, Sweden
        • Research Site
      • Varekil, Sweden
        • Research Site
      • Vasteras, 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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provision of informed consent
  • Male or female, aged 18-65 years
  • History of GERD symptoms during, at least, six months prior to enrolment
  • PPI as maintenance treatment during the last 30 days prior to enrolment
  • Heartburn as predominant GERD symptom, as judged by the investigator
  • Persisting GERD symptoms during the past 7 days prior to visit 1, judged by the patient as either: 4 days with mild symptoms (i.e. awareness of sign or symptom, but easily tolerated)or 2 days with moderate (i.e. discomfort sufficient to cause interference with normal activities) to severe symptoms (i.e. incapacitating, with inability to perform normal activities)

Exclusion Criteria:

  • Any treatment with esomeprazole during 30 days prior to enrolment History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer
  • Current or historical evidence of the following diseases/conditions, as judged by the investigator:Zollinger-Ellison syndrome,Primary esophageal motility disorder, i.e. achalasia, scleroderma, primary esophageal spasm,
  • Gastric or duodenal ulcers within the last three months, Malabsorbtion
  • Malignancy or other concomitant disease with poor prognosis or which may interfere with the assessments in the study
  • Unstable diabetes mellitus. Stable diabetes controlled by diet, oral agents or insulin is acceptable
  • Patients with severe diseases or disorders which may interfere with the conduct of the study

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
The proportion of patients free from heartburn

Secondary Outcome Measures

Outcome Measure
Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
EuroQol 5D questionnaire.
Quality Assurance of GERD Treatment Questionnaire
Willingness to pay
Serious Adverse Events and Discontinuations due to Adverse Events

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: AstraZeneca Sweden Medical 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

December 1, 2005

Study Completion (Actual)

February 1, 2007

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

March 6, 2009

Last Update Submitted That Met QC Criteria

March 5, 2009

Last Verified

August 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612L00085
  • IMPROVE
  • EudraCT-number 2005-000458-57

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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