Nexium vs. Surgery

Condition(s) targeted: Gastroesophageal Reflux

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

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Nexium Medical Sciences Director, MD, Study Director, Affiliation: AstraZeneca
Lars Lundell, MD, PhD, Principal Investigator, Affiliation: Karolinska University Hospital

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.

Official title: An Open, Randomized, Multicenter, Phase IIIB Study During 5 Years to Assess Long-Term Efficacy and Tolerability of Esomeprazole Compared to Laparoscopic Anti-Reflux Surgery in Adult Subjects With Gastroesophageal Reflux Disease - LOTUS.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Time to treatment failure defined as need for medical treatment other than esomeprazole for control of reflux disease symptom

Secondary outcome:

Efficacy endpoints including histopathological changes, scores of symptom variables, endoscopic assessments, assessment of 24h pH & Safety variables including lab tests, & all serious adverse events

Quality of life including patient reported outcomes assessed by GSRS & QOLRAD

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

Research Site, Wien, Austria

Research Site, Linz, Austria

Research Site, Zell am See, Austria

Research Site, Leuven, Belgium

Research Site, Brussels (Woluwé-St-Lambert), Belgium

Research Site, Brussels (Anderlecht), Belgium

Research Site, Brussels, Belgium

Research Site, Gent, Belgium

Research Site, Liège, Belgium

Research Site, Rimavska Sobota, Belgium

Research Site, Haine-Saint-Paul, Belgium

Research Site, Århus C, Denmark

Research Site, Viborg, Denmark

Research Site, Herning, Denmark

Research Site, Kolding, Denmark

Research Site, Odense C, Denmark

Research Site, Hillerød, Denmark

Research Site, Glostrup, Denmark

Research Site, Hvidovre, Denmark

Research Site, TAMPERE, Finland

Research Site, KUOPIO, Finland

Research Site, NANTES, France

Research Site, BORDEAUX, France

Research Site, ROUEN, France

Research Site, GRENOBLE Cedex 09, France

Research Site, CRETEIL, France

Research Site, NICE, France

Research Site, NIMES Cedex 4, France

Research Site, Würzburg, Germany

Research Site, Wiesbaden, Germany

Research Site, Köln, Germany

Research Site, Hamburg, Germany

Research Site, Tübingen, Germany

Research Site, München, Germany

Research Site, Heidelberg, Germany

Research Site, 01307 Dresden, Germany

Research Site, Herne, Germany

Research Site, Frankfurt, Germany

Research Site, Reykjavik, Iceland

Research Site, San Donato Milanese, Italy

Research Site, Padova, Italy

Research Site, Modena, Italy

Research Site, Torino, Italy

Research Site, Monfalcone, Italy

Research Site, Pisa, Italy

Research Site, Perugia, Italy

Research Site, Rozzano, Italy

Research Site, Brescia, Italy

Research Site, Firenze, Italy

Research Site, UTRECHT, Netherlands

Research Site, Bergen, Norway

Research Site, Trondheim, Norway

Research Site, Oslo, Norway

Research Site, KRISTIANSAND S, Norway

Research Site, Tromsø, Norway

Research Site, Bodø, Norway

Research Site, Göteborg, Sweden

Research Site, LUND, Sweden

Research Site, Salford, United Kingdom

Starting date: October 2001
Ending date: December 2013
Last updated: January 11, 2008