Sopran - Omeprazole Treatment Versus Surgery

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: GERD

Treatments: Drug: Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00256737

SH OMG 0004

D9584C00004

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)