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
  Purpose

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


Condition Intervention Phase
GERD
Drug: Omeprazole
Phase 3

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:


Further study details as provided by AstraZeneca:

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

ClinicalTrials.gov processed this record on October 23, 2014