Esomeprazole in PPI Failures - IMPROVE

Launched by ASTRAZENECA · Jan 4, 2006

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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