Esomeprazole (NEXIUM) vs. Surgery (LOTUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251927
First received: November 9, 2005
Last updated: August 7, 2012
Last verified: August 2012

November 9, 2005
August 7, 2012
October 2001
April 2009   (final data collection date for primary outcome measure)
Number of Participants With Treatment Failure at 5 Years [ Time Frame: During 5 years ] [ Designated as safety issue: No ]
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.
  • defined as need for medical treatment other than esomeprazole for control of reflux disease symptoms)
  • Time to treatment failure
Complete list of historical versions of study NCT00251927 on ClinicalTrials.gov Archive Site
  • Los Angeles (LA) Grade 'Normal' at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]

    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

  • Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe) 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 [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
    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
  • Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
    Intra-gastric acid exposures assessed by 24-h pH-metry. Only participants with pH-emtry performed at 5 year visit included
  • Los Angeles (LA) Grade 'A' at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]

    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

  • Los Angeles (LA) Grade 'B' at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]

    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

  • Los Angeles (LA) Grade C at 5 Year Visit [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]

    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

  • Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with mild heartburn
  • Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with moderate heartburn
  • Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn [ Time Frame: At 5 year visit ] [ Designated as safety issue: No ]
    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn
  • - 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
Not Provided
Not Provided
 
Esomeprazole (NEXIUM) vs. Surgery
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Gastroesophageal Reflux
  • Drug: esomeprazole
    40 mg oral tablet administered daily
    Other Name: Nexium®
  • Procedure: Laparoscopic fundoplication (surgery)
    Surgery
  • Active Comparator: 1
    Surgery
    Intervention: Procedure: Laparoscopic fundoplication (surgery)
  • Experimental: 2
    Esomeprazole (NEXIUM) therapy
    Intervention: Drug: esomeprazole
Galmiche JP, Hatlebakk J, Attwood S, Ell C, Fiocca R, Eklund S, Långström 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
626
April 2009
April 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Belgium,   Denmark,   Finland,   France,   Germany,   Iceland,   Italy,   Netherlands,   Norway,   Sweden,   United Kingdom
 
NCT00251927
D9612C00003, SH-NEG-0003
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
Principal Investigator: Lars Lundell, MD, PhD Karolinska University Hospital
AstraZeneca
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP