Esomeprazole (NEXIUM) vs. Surgery
LOTUS
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.
2 other identifiers
interventional
626
12 countries
59
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2001
Longer than P75 for phase_3
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2001
CompletedFirst Submitted
Initial submission to the registry
November 9, 2005
CompletedFirst Posted
Study publicly available on registry
November 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2009
CompletedResults Posted
Study results publicly available
August 8, 2012
CompletedAugust 8, 2012
August 1, 2012
7.5 years
November 9, 2005
July 8, 2010
August 7, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment Failure at 5 Years
Treatment failure in the surgical arm defined when need for medical treatment for control of symptoms from reflux disease. Treatment failure in the medical arm defined when need for treatment other than esomeprazole for control of symptoms of reflux disease.
During 5 years
Secondary Outcomes (10)
Los Angeles (LA) Grade 'Normal' at 5 Year Visit
At 5 year visit
Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn
At 5 year visit
Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit
At 5 year visit
Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit
At 5 year visit
Los Angeles (LA) Grade 'A' at 5 Year Visit
At 5 year visit
- +5 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATORSurgery
2
EXPERIMENTALEsomeprazole (NEXIUM) therapy
Interventions
Eligibility Criteria
You may qualify if:
- Subjects considered suitable for surgical treatment and long-term management of esomeprazole.
- History of chronic reflux esophagitis or symptomatic GERD
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (59)
Research Site
Linz, Austria
Research Site
Vienna, Austria
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Zell am See, Austria
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Brussels, Belgium
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Brussels (Anderlecht), Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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Ghent, Belgium
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Haine-Saint-Paul, Belgium
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Leuven, Belgium
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Liège, Belgium
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Rimavska Sobota, Belgium
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Århus C, Denmark
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Glostrup Municipality, Denmark
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Herning, Denmark
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Hillerød, Denmark
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Hvidovre, Denmark
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Kolding, Denmark
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Odense C, Denmark
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Viborg, Denmark
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Kuopio, Finland
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Tampere, Finland
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Bordeaux, France
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Créteil, France
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Grenoble, France
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Nantes, France
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Nice, France
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Nîmes, France
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Rouen, France
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Cologne, Germany
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Dresden, 01307, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Herne, Germany
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München, Germany
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Tübingen, Germany
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Wiesbaden, Germany
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Würzburg, Germany
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Reykjavik, Iceland
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Brescia, Italy
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Florence, Italy
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Modena, Italy
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Monfalcone, Italy
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Padua, Italy
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Perugia, Italy
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Pisa, Italy
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Rozzano, Italy
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San Donato Milanese, Italy
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Torino, Italy
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Utrecht, Netherlands
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Bergen, Norway
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Bodø, Norway
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Kristiansand, Norway
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Oslo, Norway
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Tromsø, Norway
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Trondheim, Norway
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Gothenburg, Sweden
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Lund, Sweden
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Salford, United Kingdom
Related Publications (5)
Hatlebakk JG, Zerbib F, Bruley des Varannes S, Attwood SE, Ell C, Fiocca R, Galmiche JP, Eklund S, Langstrom G, Lind T, Lundell LR; LOTUS Study Group. Gastroesophageal Acid Reflux Control 5 Years After Antireflux Surgery, Compared With Long-term Esomeprazole Therapy. Clin Gastroenterol Hepatol. 2016 May;14(5):678-85.e3. doi: 10.1016/j.cgh.2015.07.025. Epub 2015 Jul 27.
PMID: 26226096DERIVEDAttwood SE, Ell C, Galmiche JP, Fiocca R, Hatlebakk JG, Hasselgren B, Langstrom G, Jahreskog M, Eklund S, Lind T, Lundell L. Long-term safety of proton pump inhibitor therapy assessed under controlled, randomised clinical trial conditions: data from the SOPRAN and LOTUS studies. Aliment Pharmacol Ther. 2015 Jun;41(11):1162-74. doi: 10.1111/apt.13194. Epub 2015 Apr 10.
PMID: 25858519DERIVEDLundell L, Hatlebakk J, Galmiche JP, Attwood SE, Ell C, Fiocca R, Persson T, Nagy P, Eklund S, Lind T. Long-term effect on symptoms and quality of life of maintenance therapy with esomeprazole 20 mg daily: a post hoc analysis of the LOTUS trial. Curr Med Res Opin. 2015 Jan;31(1):65-73. doi: 10.1185/03007995.2014.980500. Epub 2014 Oct 31.
PMID: 25350223DERIVEDFiocca R, Mastracci L, Attwood SE, Ell C, Galmiche JP, Hatlebakk J, Barthel A, Langstrom G, Lind T, Lundell L; LOTUS trial collaborators. Gastric exocrine and endocrine cell morphology under prolonged acid inhibition therapy: results of a 5-year follow-up in the LOTUS trial. Aliment Pharmacol Ther. 2012 Nov;36(10):959-71. doi: 10.1111/apt.12052. Epub 2012 Sep 23.
PMID: 22998687DERIVEDGalmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Langstrom G, Lind T, Lundell L; LOTUS Trial Collaborators. Laparoscopic antireflux surgery vs esomeprazole treatment for chronic GERD: the LOTUS randomized clinical trial. JAMA. 2011 May 18;305(19):1969-77. doi: 10.1001/jama.2011.626.
PMID: 21586712DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY DIRECTOR
AstraZeneca Nexium Medical Sciences Director, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Lars Lundell, MD, PhD
Karolinska University Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2005
First Posted
November 11, 2005
Study Start
October 1, 2001
Primary Completion
April 1, 2009
Study Completion
April 1, 2009
Last Updated
August 8, 2012
Results First Posted
August 8, 2012
Record last verified: 2012-08