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Esomeprazole in PPI Failures - IMPROVE

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Esomeprazole
Other PPI marketed in Sweden
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

The proportion of patients free from heartburn

Secondary Outcome Measures

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

Full Information

First Posted
January 4, 2006
Last Updated
March 5, 2009
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00272701
Brief Title
Esomeprazole in PPI Failures - IMPROVE
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Type
Drug
Intervention Name(s)
Other PPI marketed in Sweden
Primary Outcome Measure Information:
Title
The proportion of patients free from heartburn
Secondary Outcome Measure Information:
Title
Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
Title
EuroQol 5D questionnaire.
Title
Quality Assurance of GERD Treatment Questionnaire
Title
Willingness to pay
Title
Serious Adverse Events and Discontinuations due to Adverse Events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Sweden Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Akersberga
Country
Sweden
Facility Name
Research Site
City
Arlov
Country
Sweden
Facility Name
Research site
City
Balsta
Country
Sweden
Facility Name
Research Site
City
Boras
Country
Sweden
Facility Name
Research Site
City
Bromma
Country
Sweden
Facility Name
Research Site
City
Bromolla
Country
Sweden
Facility Name
Research Site
City
Dalby
Country
Sweden
Facility Name
Research Site
City
Djursholm
Country
Sweden
Facility Name
Research Site
City
Enskededalen
Country
Sweden
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Grangesberg
Country
Sweden
Facility Name
Research Site
City
Harnosand
Country
Sweden
Facility Name
Research Site
City
Helsingborg
Country
Sweden
Facility Name
Research Site
City
Hollviken
Country
Sweden
Facility Name
Research Site
City
Jarfalla
Country
Sweden
Facility Name
Research Site
City
Kil
Country
Sweden
Facility Name
Research Site
City
Knäred
Country
Sweden
Facility Name
Research Site
City
Koping
Country
Sweden
Facility Name
Research Site
City
Kristinehamn
Country
Sweden
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Ludvika
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Marsta
Country
Sweden
Facility Name
Research Site
City
Nacka
Country
Sweden
Facility Name
Research Site
City
Nykoping
Country
Sweden
Facility Name
Research Site
City
Orebro
Country
Sweden
Facility Name
Research Site
City
Partille
Country
Sweden
Facility Name
Research Site
City
Pitea
Country
Sweden
Facility Name
Research Site
City
Sandviken
Country
Sweden
Facility Name
Research Site
City
Solna
Country
Sweden
Facility Name
Research Site
City
Stenstorp
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Sunne
Country
Sweden
Facility Name
Research Site
City
Trollhättan
Country
Sweden
Facility Name
Research Site
City
Täby
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Vannas
Country
Sweden
Facility Name
Research Site
City
Varberg
Country
Sweden
Facility Name
Research Site
City
Varekil
Country
Sweden
Facility Name
Research Site
City
Vasteras
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
21288053
Citation
Ekesbo R, Sjostedt S, Sorngard H. Effects of structured follow-up and of more effective acid inhibitory treatment in the management of GORD patients in a Swedish primary-care setting: a randomized, open-label study. Clin Drug Investig. 2011;31(3):181-9. doi: 10.2165/11586330-000000000-00000.
Results Reference
derived

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Esomeprazole in PPI Failures - IMPROVE

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