Sopran - Omeprazole Treatment Versus Surgery

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00256737

Enrollment

219

Registered

2005-11-22

Start date

1998-01-31

Completion date

2005-10-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

Maintenance of healed erosive esophagitis

Brief summary

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

Interventions

DRUGOmeprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Determine the safety of omeprazole during long term treatment	—

Secondary

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

Countries

Denmark, Finland, Norway, Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026