Sopran - Omeprazole Treatment Versus Surgery

This study has been completed.

First Received on November 20, 2005. Last Updated on January 21, 2011 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 III

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

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

U.S. FDA Resources

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:	January 1998
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

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

ClinicalTrials.gov Identifier:	NCT00256737 History of Changes
Other Study ID Numbers:	D9584C00004, SH OMG 0004
Study First Received:	November 20, 2005
Last Updated:	January 21, 2011
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:

Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Omeprazole

Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012