Back to resultsSopran - Omeprazole Treatment Versus Surgery
Primary Purpose
GERD
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for GERD focused on measuring Maintenance of healed erosive esophagitis
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.
Sites / Locations
- Research Site
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Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00256737
Brief Title
Sopran - Omeprazole Treatment Versus Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
October 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to study gastritis, GI symptoms during long term omeprazole treatment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
GERD
Keywords
Maintenance of healed erosive esophagitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
219 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Primary Outcome Measure Information:
Title
Determine the safety of omeprazole during long term treatment
Secondary Outcome Measure Information:
Title
To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca GI Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Aalborg
Country
Denmark
Facility Name
Research Site
City
Glostrup
Country
Denmark
Facility Name
Research Site
City
Hillerød
Country
Denmark
Facility Name
Research Site
City
Kolding
Country
Denmark
Facility Name
Research Site
City
Odense
Country
Denmark
Facility Name
Research Site
City
Roskilde
Country
Denmark
Facility Name
Research Site
City
Kuopio
Country
Finland
Facility Name
Research Site
City
Bergen
Country
Norway
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Örebro
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
25858519
Citation
Attwood SE, Ell C, Galmiche JP, Fiocca R, Hatlebakk JG, Hasselgren B, Langstrom G, Jahreskog M, Eklund S, Lind T, Lundell L. Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies. Aliment Pharmacol Ther. 2015 Jun;41(11):1162-74. doi: 10.1111/apt.13194. Epub 2015 Apr 10.
Results Reference
derived
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Sopran - Omeprazole Treatment Versus Surgery
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