Esomeprazole in PPI Failures - IMPROVE
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.
3 other identifiers
interventional
450
1 country
42
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2005
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 4, 2006
CompletedFirst Posted
Study publicly available on registry
January 9, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedMarch 6, 2009
August 1, 2007
January 4, 2006
March 5, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of patients free from heartburn
Secondary Outcomes (5)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (42)
Research Site
Arlöv, Sweden
Research Site
Åkersberga, Sweden
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Bålsta, Sweden
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Borås, Sweden
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Bromma, Sweden
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Bromölla, Sweden
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Dalby, Sweden
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Djursholm, Sweden
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Enskededalen, Sweden
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Gothenburg, Sweden
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Grängesberg, Sweden
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Härnösand, Sweden
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Helsingborg, Sweden
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Höllviken, Sweden
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Jarfalla, Sweden
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Kil, Sweden
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Knäred, Sweden
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Köping, Sweden
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Kristinehamn, Sweden
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Linköping, Sweden
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Ludvika, Sweden
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Luleå, Sweden
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Lund, Sweden
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Malmo, Sweden
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Märsta, Sweden
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Nacka, Sweden
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Nyköping, Sweden
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Örebro, Sweden
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Partille, Sweden
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Piteå, Sweden
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Sandviken, Sweden
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Solna, Sweden
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Stenstorp, Sweden
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Stockholm, Sweden
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Sunne, Sweden
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Täby, Sweden
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Trollhättan, Sweden
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Uppsala, Sweden
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Varberg, Sweden
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Varekil, Sweden
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Vännäs, Sweden
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Västerås, Sweden
Related Publications (1)
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.
PMID: 21288053DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Sweden Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 4, 2006
First Posted
January 9, 2006
Study Start
December 1, 2005
Study Completion
February 1, 2007
Last Updated
March 6, 2009
Record last verified: 2007-08