Sopran - Omeprazole Treatment Versus Surgery
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: GERD
Intervention: Omeprazole (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
AstraZeneca GI Medical Science Director, MD, Study Director, Affiliation: AstraZeneca
Summary
The purpose of this study is to study gastritis, GI symptoms during long term omeprazole
treatment
Clinical Details
Official title: Omeprazole Versus Anti-Reflux Surgery in the Long-Term Management of Peptic Esophagitis – a 10 Year Follow up Study of Patients Previously Studied for 5 Years – A Nordic Multicentre Study
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Primary outcome: Determine the safety of omeprazole during long term treatment
Secondary outcome: To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Previous inclusion into Astra study I-635 and willing to continue for another 10
years,
Exclusion Criteria:
- Pregnancy or lactation; Woman planning pregnancy within 5 years; Suspected or
confirmed malignancy; Documented eradication of Helicobacter pylori.
Locations and Contacts
Research Site, Odense, Denmark
Research Site, Aalborg, Denmark
Research Site, Kolding, Denmark
Research Site, Glostrup, Denmark
Research Site, Hillerød, Denmark
Research Site, Roskilde, Denmark
Research Site, Kuopio, Finland
Research Site, Oslo, Norway
Research Site, Bergen, Norway
Research Site, Trondheim, Norway
Research Site, Ãrebro, Sweden
Research Site, Göteborg, Sweden
Research Site, Stockholm, Sweden
Additional Information
Starting date: February 2001
Last updated: November 21, 2006
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