Esomeprazole in PPI Failures - IMPROVE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00272701
Recruitment Status : Completed
First Posted : January 9, 2006
Last Update Posted : March 6, 2009
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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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Disease Drug: Esomeprazole Drug: Other PPI marketed in Sweden Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Primary Outcome Measures :
  1. The proportion of patients free from heartburn

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00272701

Research Site
Akersberga, Sweden
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Arlov, Sweden
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Balsta, Sweden
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Boras, Sweden
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Bromma, Sweden
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Bromolla, Sweden
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Dalby, Sweden
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Djursholm, Sweden
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Enskededalen, Sweden
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Goteborg, Sweden
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Grangesberg, Sweden
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Harnosand, Sweden
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Helsingborg, Sweden
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Hollviken, Sweden
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Jarfalla, Sweden
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Kil, Sweden
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Knäred, Sweden
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Koping, Sweden
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Kristinehamn, Sweden
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Linkoping, Sweden
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Ludvika, Sweden
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Lulea, Sweden
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Lund, Sweden
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Malmo, Sweden
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Marsta, Sweden
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Nacka, Sweden
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Nykoping, Sweden
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Orebro, Sweden
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Partille, Sweden
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Pitea, 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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Trollhättan, Sweden
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Täby, Sweden
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Uppsala, Sweden
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Vannas, Sweden
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Varberg, Sweden
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Varekil, Sweden
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Vasteras, Sweden
Sponsors and Collaborators
Study Director: AstraZeneca Sweden Medical Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00272701     History of Changes
Other Study ID Numbers: D9612L00085
EudraCT-number 2005-000458-57
First Posted: January 9, 2006    Key Record Dates
Last Update Posted: March 6, 2009
Last Verified: August 2007

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action