Sopran - Omeprazole Treatment Versus Surgery

Phase 3

Completed

• Conditions: GERD

• Registration Number: NCT00256737
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1998-01
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2005-11-20
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determine the safety of omeprazole during long term treatment

Secondary Outcome Measures

Name	Time	Method
To investigate the long term control of reflux symptoms, healing of esophagitis and persistence of post fundoplication symptoms during long term treatment of omeprazole

Trial Locations

Locations (1)

Research Site; 🇸🇪 Örebro, Sweden