NCT Number: NCT00272701
Esomeprazole in PPI Failures - IMPROVE
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.
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Conditions
Age range
18 year–65 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
Primary location
Research Site, Arlöv, Sweden
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Other PPI marketed in Sweden
DrugPrimary outcomes
-
The proportion of patients free from heartburn
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Official study 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.
Important dates
- Study start
- 2005
- Study completion
- 2007
- First posted
- Jan 9, 2006
- Registry last updated
- Mar 6, 2009
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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