Sopran - Omeprazole Treatment Versus Surgery
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00256737
First received: November 20, 2005
Last updated: January 21, 2011
Last verified: January 2011
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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:
MedlinePlus related topics:
GERD
Drug Information available for:
Omeprazole
Omeprazole magnesium
Esomeprazole
Esomeprazole Sodium
Esomeprazole magnesium
U.S. FDA Resources
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
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:
|
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 May 23, 2013