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
Information provided by:

January 4, 2006
January 9, 2006
March 6, 2009
December 2005
Not Provided
The proportion of patients free from heartburn
Same as current
Complete list of historical versions of study NCT00272701 on Archive Site
  • 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
Same as current
Not Provided
Not Provided
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.
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.
Not Provided
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • Drug: Esomeprazole
  • Drug: Other PPI marketed in Sweden
Not Provided
Ekesbo R, Sjöstedt S, Sörngård 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
February 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
EudraCT-number 2005-000458-57
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Study Director: AstraZeneca Sweden Medical Director, MD AstraZeneca
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP