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Esomeprazole (NEXIUM) vs. Surgery

NCT00251927 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 626

Last updated 2012-08-08

Study results available
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Summary

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.

Conditions

  • Gastroesophageal Reflux

Interventions

DRUG

esomeprazole

40 mg oral tablet administered daily

PROCEDURE

Laparoscopic fundoplication (surgery)

Surgery

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca Nexium Medical Sciences Director, MD · AstraZeneca

  • Lars Lundell, MD, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2009-04-30
Completion
2009-04-30

Countries

  • Austria
  • Belgium
  • Denmark
  • Finland
  • France
  • Germany
  • Iceland
  • Italy
  • Netherlands
  • Norway
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251927 on ClinicalTrials.gov