Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
626 participants
INTERVENTIONAL
2001-10-31
2009-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Surgery
Laparoscopic fundoplication (surgery)
Surgery
2
Esomeprazole (NEXIUM) therapy
esomeprazole
40 mg oral tablet administered daily
Interventions
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esomeprazole
40 mg oral tablet administered daily
Laparoscopic fundoplication (surgery)
Surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* History of chronic reflux esophagitis or symptomatic GERD
Exclusion Criteria
* Contraindication to the study drug.
* Pregnancy, lactating or of child-bearing potential.
18 Years
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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AstraZeneca Nexium Medical Sciences Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Lars Lundell, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital
Locations
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Research Site
Linz, , Austria
Research Site
Vienna, , Austria
Research Site
Zell am See, , Austria
Research Site
Brussels, , Belgium
Research Site
Brussels (Anderlecht), , Belgium
Research Site
Brussels (Woluwé-St-Lambert), , Belgium
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Ghent, , Belgium
Research Site
Haine-Saint-Paul, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Rimavska Sobota, , Belgium
Research Site
Århus C, , Denmark
Research Site
Glostrup Municipality, , Denmark
Research Site
Herning, , Denmark
Research Site
Hillerød, , Denmark
Research Site
Hvidovre, , Denmark
Research Site
Kolding, , Denmark
Research Site
Odense C, , Denmark
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Viborg, , Denmark
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Kuopio, , Finland
Research Site
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, , 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
Research Site
San Donato Milanese, , Italy
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Torino, , Italy
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Utrecht, , Netherlands
Research Site
Bergen, , Norway
Research Site
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
Research Site
Lund, , Sweden
Research Site
Salford, , United Kingdom
Countries
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References
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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.
Attwood 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.
Lundell 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.
Fiocca 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.
Galmiche 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.
Other Identifiers
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SH-NEG-0003
Identifier Type: -
Identifier Source: secondary_id
D9612C00003
Identifier Type: -
Identifier Source: org_study_id