Esomeprazole in PPI Failures - IMPROVE

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00272701
First received: January 4, 2006
Last updated: March 5, 2009
Last verified: August 2007
  Purpose

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 Intervention Phase
Gastroesophageal Reflux Disease
Drug: Esomeprazole
Drug: Other PPI marketed in Sweden
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 450
Study Start Date: December 2005
Study Completion Date: February 2007
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272701

Locations
Sweden
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Sweden Medical Director, MD AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00272701     History of Changes
Other Study ID Numbers: D9612L00085, IMPROVE, EudraCT-number 2005-000458-57
Study First Received: January 4, 2006
Last Updated: March 5, 2009
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on August 21, 2014