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NCT00256737 Clinical Trial

Sopran - Omeprazole Treatment Versus Surgery

GERD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00256737
Other study ID # D9584C00004
Secondary ID SH OMG 0004
Status Completed
Phase Phase 3
First received November 20, 2005
Last updated January 21, 2011
Start date January 1998
Est. completion date October 2005

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products AgencyNorway: Norwegian Medicines AgencyDenmark: Danish Medicines AgencyFinland: Finnish Medicines Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment

Recruitment information / eligibility
Status Completed
Enrollment 219
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Omeprazole

Locations
Country Name City State
Denmark Research Site Aalborg
Denmark Research Site Glostrup
Denmark Research Site Hillerød
Denmark Research Site Kolding
Denmark Research Site Odense
Denmark Research Site Roskilde
Finland Research Site Kuopio
Norway Research Site Bergen
Norway Research Site Oslo
Norway Research Site Trondheim
Sweden Research Site Göteborg
Sweden Research Site Örebro
Sweden Research Site Stockholm

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

Denmark,  Finland,  Norway,  Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Determine the safety of omeprazole during long term treatment
Secondary To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
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