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Esomeprazole (NEXIUM) vs. Surgery

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux

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

Phase: Phase 3

Status: Completed

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

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.

Clinical Details

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Participants With Treatment Failure at 5 Years

Secondary outcome:

Los Angeles (LA) Grade 'Normal' at 5 Year Visit

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn

Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit

Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit

Los Angeles (LA) Grade 'A' at 5 Year Visit

Los Angeles (LA) Grade 'B' at 5 Year Visit

Los Angeles (LA) Grade C at 5 Year Visit

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn

Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn

Eligibility

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.

Locations and Contacts

Research Site, Linz, Austria

Research Site, Wien, Austria

Research Site, Zell am See, Austria

Research Site, Brussels (Anderlecht), Belgium

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

Research Site, Brussels, Belgium

Research Site, Gent, Belgium

Research Site, Haine-Saint-Paul, Belgium

Research Site, Leuven, Belgium

Research Site, Liège, Belgium

Research Site, Rimavska Sobota, Belgium

Research Site, Glostrup, Denmark

Research Site, Herning, Denmark

Research Site, Hillerød, Denmark

Research Site, Hvidovre, Denmark

Research Site, Kolding, Denmark

Research Site, Odense C, Denmark

Research Site, Viborg, Denmark

Research Site, Århus C, Denmark

Research Site, Kuopio, Finland

Research Site, Tampere, Finland

Research Site, Bordeaux, France

Research Site, Creteil, France

Research Site, GRENOBLE Cedex 09, France

Research Site, Nantes, France

Research Site, Nice, France

Research Site, NIMES Cedex 4, France

Research Site, Rouen, France

Research Site, Dresden 01307, Germany

Research Site, Frankfurt, Germany

Research Site, Hamburg, Germany

Research Site, Heidelberg, Germany

Research Site, Herne, Germany

Research Site, Köln, Germany

Research Site, München, Germany

Research Site, Tübingen, Germany

Research Site, Wiesbaden, Germany

Research Site, Würzburg, Germany

Research Site, Reykjavik, Iceland

Research Site, Brescia, Italy

Research Site, Firenze, Italy

Research Site, Modena, Italy

Research Site, Monfalcone, Italy

Research Site, Padova, Italy

Research Site, Perugia, Italy

Research Site, Pisa, Italy

Research Site, Rozzano, Italy

Research Site, San Donato Milanese, Italy

Research Site, Torino, Italy

Research Site, Utrecht, Netherlands

Research Site, Bergen, Norway

Research Site, Bodø, Norway

Research Site, Kristiansand S, Norway

Research Site, Oslo, Norway

Research Site, Tromsø, Norway

Research Site, Trondheim, Norway

Research Site, Göteborg, Sweden

Research Site, Lund, Sweden

Research Site, Salford, United Kingdom

Additional Information

Starting date: October 2001
Last updated: August 7, 2012

Page last updated: August 23, 2015

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