Sopran - Omeprazole Treatment Versus Surgery

This study has been completed.

Sponsor:

Information provided by:

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00256737

First received: November 20, 2005

Last updated: January 21, 2011

Last verified: January 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 20, 2005

Last Updated Date

January 21, 2011

Start Date ^ICMJE

January 1998

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Determine the safety of omeprazole during long term treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00256737 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Sopran - Omeprazole Treatment Versus Surgery

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

GERD

Intervention ^ICMJE

Drug: Omeprazole

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

219

Completion Date

October 2005

Primary Completion Date

October 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, Finland, Norway, Sweden

Administrative Information

NCT Number ^ICMJE

NCT00256737

Other Study ID Numbers ^ICMJE

D9584C00004, SH OMG 0004

Has Data Monitoring Committee

Responsible Party

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca GI Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

January 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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