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Sopran - Omeprazole Treatment Versus Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00256737
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment

Condition or disease Intervention/treatment Phase
GERD Drug: Omeprazole Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 219 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 1998
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Determine the safety of omeprazole during long term treatment

Secondary Outcome Measures :
  1. To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00256737


Locations
Denmark
Research Site
Aalborg, Denmark
Research Site
Glostrup, Denmark
Research Site
Hillerød, Denmark
Research Site
Kolding, Denmark
Research Site
Odense, Denmark
Research Site
Roskilde, Denmark
Finland
Research Site
Kuopio, Finland
Norway
Research Site
Bergen, Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Sweden
Research Site
Göteborg, Sweden
Research Site
Stockholm, Sweden
Research Site
Örebro, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca GI Medical Science Director, MD AstraZeneca
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00256737     History of Changes
Other Study ID Numbers: D9584C00004
SH OMG 0004
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Maintenance of healed erosive esophagitis

Additional relevant MeSH terms:
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action