Sopran - Omeprazole Treatment Versus Surgery

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

Completed

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Key information

Conditions

GERD Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Omeprazole

Drug

Primary outcomes

Determine the safety of omeprazole during long term treatment

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 1998
Primary completion: 2005
Study completion: 2005
First posted: Nov 22, 2005
Registry last updated: Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed