Esomeprazole (NEXIUM) vs. Surgery (LOTUS)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gastroesophageal Reflux

Treatments: Procedure: Laparoscopic fundoplication (surgery); Drug: esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00251927

SH-NEG-0003

D9612C00003

Details and patient eligibility

About

The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.

Enrollment: 626 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
• History of chronic reflux esophagitis or symptomatic GERD

Exclusion criteria

• History of esophageal, gastric, or duodenal surgery predicted to influence negatively on subsequent treatment within the study.
• Contraindication to the study drug.
• Pregnancy, lactating or of child-bearing potential.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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626 participants in 2 patient groups

1

Active Comparator group

Description:

Surgery

Treatment:

Procedure: Laparoscopic fundoplication (surgery)

2

Experimental group

Description:

Esomeprazole (NEXIUM) therapy

Treatment:

Drug: esomeprazole