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Esomeprazole (NEXIUM) vs. Surgery (LOTUS)

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ClinicalTrials.gov Identifier: NCT00251927
Recruitment Status : Completed
First Posted : November 11, 2005
Results First Posted : August 8, 2012
Last Update Posted : August 8, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE November 9, 2005
First Posted Date  ICMJE November 11, 2005
Results First Submitted Date  ICMJE July 8, 2010
Results First Posted Date  ICMJE August 8, 2012
Last Update Posted Date August 8, 2012
Study Start Date  ICMJE October 2001
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
Number of Participants With Treatment Failure at 5 Years [ Time Frame: During 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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 9, 2005)
  • Time to treatment failure
  • defined as need for medical treatment other than esomeprazole for control of reflux disease symptoms)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2012)
  • Los Angeles (LA) Grade 'Normal' at 5 Year Visit [ Time Frame: 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
  • Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn [ Time Frame: At 5 year visit ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Presence of heartburn assessed retrospectively by the investigator. Classified by severity (none, mild, moderate, severe). Participants with severe heartburn
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2005)
  • - 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Esomeprazole (NEXIUM) vs. Surgery
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastroesophageal Reflux
Intervention  ICMJE
  • Drug: esomeprazole
    40 mg oral tablet administered daily
    Other Name: Nexium®
  • Procedure: Laparoscopic fundoplication (surgery)
    Surgery
Study Arms  ICMJE
  • Active Comparator: 1
    Surgery
    Intervention: Procedure: Laparoscopic fundoplication (surgery)
  • Experimental: 2
    Esomeprazole (NEXIUM) therapy
    Intervention: Drug: esomeprazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 7, 2010)
626
Original Enrollment  ICMJE
 (submitted: November 9, 2005)
550
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Denmark,   Finland,   France,   Germany,   Iceland,   Italy,   Netherlands,   Norway,   Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00251927
Other Study ID Numbers  ICMJE D9612C00003
SH-NEG-0003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AstraZeneca Nexium Medical Sciences Director, MD AstraZeneca
Principal Investigator: Lars Lundell, MD, PhD Karolinska University Hospital
PRS Account AstraZeneca
Verification Date August 2012

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