Esomeprazole in PPI Failures - IMPROVE

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease

• Registration Number: NCT00272701
• Lead Sponsor: AstraZeneca

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 during 4 weeks, by evaluation of esomeprazole 40 mg compared to pre-study PPI treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-09
• Study Completion: 2007-02
• Status Verified: 2007-08
• Last Update Submitted: 2009-03-05
• Last Update Posted: 2009-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The proportion of patients free from heartburn

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Research site; 🇸🇪 Balsta, Sweden

Research Site; 🇸🇪 Vasteras, Sweden