Esomeprazole (NEXIUM) vs. Surgery

Gastroesophageal Reflux Clinical Trial

— LOTUS  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00251927
• Other study ID #: D9612C00003
• Secondary ID: SH-NEG-0003
• Status: Completed
• Phase: Phase 3
• First received: November 9, 2005
• Last updated: August 7, 2012
• Start date: October 2001
• Est. completion date: April 2009

Study information

• Verified date: August 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• esomeprazole
40 mg oral tablet administered daily

Procedure:
• Laparoscopic fundoplication (surgery)
Surgery

Locations

Country	Name	City	State
Austria	Research Site	Linz
Austria	Research Site	Wien
Austria	Research Site	Zell am See
Belgium	Research Site	Brussels
Belgium	Research Site	Brussels (Anderlecht)
Belgium	Research Site	Brussels (Woluwé-St-Lambert)
Belgium	Research Site	Gent
Belgium	Research Site	Haine-Saint-Paul
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Belgium	Research Site	Rimavska Sobota
Denmark	Research Site	Århus C
Denmark	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
Finland	Research Site	Kuopio
Finland	Research Site	Tampere
France	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
Germany	Research Site	Dresden
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
Iceland	Research Site	Reykjavik
Italy	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
Netherlands	Research Site	Utrecht
Norway	Research Site	Bergen
Norway	Research Site	Bodø
Norway	Research Site	Kristiansand S
Norway	Research Site	Oslo
Norway	Research Site	Tromsø
Norway	Research Site	Trondheim
Sweden	Research Site	Göteborg
Sweden	Research Site	Lund
United Kingdom	Research Site	Salford

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Los Angeles (LA) Grade 'Normal' at 5 Year Visit	Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference	At 5 year visit	No
Secondary	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) Participants with no heartburn	At 5 year visit	No
Secondary	Total Score for Microscopic Reflux-related Changes in the Distal Esophagus 2 cm Above the Z-line, at 5 Year Visit	The total score expressed as a mean of all the scores/number of lesions assessed; scored 2 when erosion/necrosis is found. The score could range from 0 to 2 (maximum severity). Only participants with biopsy at 5 years visit included	At 5 year visit	No
Secondary	Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit	Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included	At 5 year visit	No
Secondary	Los Angeles (LA) Grade 'A' at 5 Year Visit	Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference	At 5 year visit	No
Secondary	Los Angeles (LA) Grade 'B' at 5 Year Visit	Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference	At 5 year visit	No
Secondary	Los Angeles (LA) Grade C at 5 Year Visit	Endoscopic findings classified according to the Los Angeles classification: Grade Normal - endoscopy reveals no mucosal break Grade A- one or more mucosal breaks <5 mm in maximal length Grade B - one or more mucosal breaks >5 mm, but without continuity across mucosal folds Grade C - Mucosal breaks continuous between >2 mucosal folds, but involving less than 75% of the esophageal circumference Grade D - Mucosal breaks involving more than 75% of the esophageal circumference	At 5 year visit	No
Secondary	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn	At 5 year visit	No
Secondary	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn	At 5 year visit	No
Secondary	Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn	Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn	At 5 year visit	No