Status:
COMPLETED
Esomeprazole in PPI Failures - IMPROVE
Lead Sponsor:
AstraZeneca
Conditions:
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT00272701
Start Date
December 1 2005
End Date
February 1 2007
Last Update
March 6 2009
Active Locations (42)
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1
Research Site
Arlöv, Sweden
2
Research Site
Åkersberga, Sweden
3
Research site
Bålsta, Sweden
4
Research Site
Borås, Sweden