Sopran - Omeprazole Treatment Versus Surgery - Full Text View

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

ChemIDplus related topics:

Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

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

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

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

Keywords provided by AstraZeneca:

Maintenance of healed erosive esophagitis

Study placed in the following topic categories:

Esophagitis

Esophagitis, Peptic

Omeprazole

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action

Therapeutic Uses

Anti-Ulcer Agents

Gastrointestinal Agents

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 19, 2008

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