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Sopran - Omeprazole Treatment Versus Surgery

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: GERD

Intervention: Omeprazole (Drug)

Phase: Phase 3

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: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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, Aalborg, Denmark

Research Site, Glostrup, Denmark

Research Site, Hillerød, Denmark

Research Site, Kolding, Denmark

Research Site, Odense, Denmark

Research Site, Roskilde, Denmark

Research Site, Kuopio, Finland

Research Site, Bergen, Norway

Research Site, Oslo, Norway

Research Site, Trondheim, Norway

Research Site, Göteborg, Sweden

Research Site, Stockholm, Sweden

Research Site, Örebro, Sweden

Additional Information

Starting date: January 1998
Last updated: January 21, 2011

Page last updated: August 23, 2015

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