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
Results First Received: July 8, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Gastroesophageal Reflux
Interventions: Drug: esomeprazole
Procedure: Laparoscopic fundoplication (surgery)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The first patient was enrolled on 16 October 2001. Last patient completed the last visit on 07 April 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study started with a 12-week run-in period. Patients had either been treated or untreated with a proton pump inhibitor (PPI) prior to entering this phase of the study.

Reporting Groups
  Description
Esomeprazole Surgical Arm Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
Esomeprazole Medical Arm Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)

Participant Flow:   Overall Study
    Esomeprazole Surgical Arm     Esomeprazole Medical Arm  
STARTED     288 [1]   266 [1]
COMPLETED     180 [2]   192 [2]
NOT COMPLETED     108     74  
Adverse Event                 3                 15  
Lack of Efficacy                 22                 16  
Lost to Follow-up                 22                 8  
Protocol Violation                 1                 2  
Pregnancy                 2                 0  
Withdrawal by Subject                 40                 25  
Study-specific discont. achieved                 13                 2  
Study procedure non-compliance                 5                 6  
[1] Randomised
[2] Completed 5 year visit



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Esomeprazole Surgical Arm Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
Esomeprazole Medical Arm Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
Total Total of all reporting groups

Baseline Measures
    Esomeprazole Surgical Arm     Esomeprazole Medical Arm     Total  
Number of Participants  
[units: participants]
  288     266     554  
Age  
[units: Years]
Mean ± Standard Deviation
  44.8  ± 10.9     45.3  ± 11.5     45.05  ± 11.2  
Gender  
[units: Participants]
     
Female     89     67     156  
Male     199     199     398  



  Outcome Measures
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1.  Primary:   Number of Participants With Treatment Failure at 5 Years   [ Time Frame: During 5 years ]

2.  Secondary:   Los Angeles (LA) Grade 'Normal' at 5 Year Visit   [ Time Frame: At 5 year visit ]

3.  Secondary:   Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With no Heartburn   [ Time Frame: At 5 year visit ]

4.  Secondary:   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 ]

5.  Secondary:   Percentage Time With pH<4 During 24-hour pH Metry at 5 Year Visit   [ Time Frame: At 5 year visit ]

6.  Secondary:   Los Angeles (LA) Grade 'A' at 5 Year Visit   [ Time Frame: At 5 year visit ]

7.  Secondary:   Los Angeles (LA) Grade 'B' at 5 Year Visit   [ Time Frame: At 5 year visit ]

8.  Secondary:   Los Angeles (LA) Grade C at 5 Year Visit   [ Time Frame: At 5 year visit ]

9.  Secondary:   Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Mild Heartburn   [ Time Frame: At 5 year visit ]

10.  Secondary:   Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Moderate Heartburn   [ Time Frame: At 5 year visit ]

11.  Secondary:   Investigator-assessed Heartburn Severity at 5 Year Visit, Participants With Severe Heartburn   [ Time Frame: At 5 year visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com


No publications provided by AstraZeneca

Publications automatically indexed to this study:

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00251927     History of Changes
Other Study ID Numbers: D9612C00003, SH-NEG-0003
Study First Received: November 9, 2005
Results First Received: July 8, 2010
Last Updated: August 7, 2012
Health Authority: Norway: Norwegian Medicines Agency