Esomeprazole in PPI Failures - IMPROVE

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Gastroesophageal Reflux Disease

Treatments

Drug: Other PPI marketed in Sweden

Drug: Esomeprazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272701

IMPROVE

D9612L00085

EudraCT-number 2005-000458-57

Details and patient eligibility

About

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.

Enrollment

450 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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