Sopran - Omeprazole Treatment Versus Surgery

This study has been completed.

First Received: November 20, 2005 Last Updated: November 21, 2006 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00256737

Purpose

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

Condition	Intervention	Phase
GERD	Drug: Omeprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
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

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Estimated Enrollment:	219
Study Start Date:	February 2001

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00256737

Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca GI Medical Science Director, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9584C00004, SH OMG 0004
Study First Received:	November 20, 2005
Last Updated:	November 21, 2006
ClinicalTrials.gov Identifier:	NCT00256737 History of Changes
Health Authority:	Sweden: Medical Products Agency; Norway: Norwegian Medicines Agency; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency

Keywords provided by AstraZeneca:

Maintenance of healed erosive esophagitis

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents

Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010