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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00272701 |
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Date of registration:
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04/01/2006 |
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Primary sponsor: |
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Public title:
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Esomeprazole in PPI Failures - IMPROVE
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Scientific title:
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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. |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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450 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00272701 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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AstraZeneca Sweden Medical Director, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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AstraZeneca |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Gastroesophageal Reflux Disease
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Intervention(s)
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Drug: Esomeprazole
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Drug: Other PPI marketed in Sweden
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Primary Outcome(s)
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The proportion of patients free from heartburn
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Secondary Outcome(s)
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EuroQol 5D questionnaire.
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Quality Assurance of GERD Treatment Questionnaire
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Serious Adverse Events and Discontinuations due to Adverse Events
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Willingness to pay
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Work Productivity and Activity Impairment Questionnaire: Gastro-Esophageal Reflux Disease questionnaire.
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Secondary ID(s)
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D9612L00085
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EudraCT-number 2005-000458-57
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IMPROVE
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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