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Esomeprazole Magnesium With or Without Aspirin in Preventing Esophageal Cancer in Patients With Barrett Esophagus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00474903
First received: May 16, 2007
Last updated: June 2, 2014
Last verified: January 2014
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Conditions: Barrett Esophagus
Esophageal Cancer
Interventions: Drug: acetylsalicylic acid
Drug: esomeprazole magnesium
Other: placebo

  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
In total, 122 patients were randomized. Two patients withdrew due to an inadequate number of biopsies and a finding of high-grade dysplasia. Six participants were not evaluable for the primary endpoint due to sample-related issues (e.g., improper temperature, lost or delayed samples), leaving 114 evaluable participants for the primary endpoint.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 120 participants in the intervention cohort, 114 were evaluable for the primary endpoint (n = 29, 42, and 43 in Arm I, Arm II, and Arm III, respectively).

Reporting Groups
  Description
Arm I (Placebo, Esomeprazole Magnesium)

Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).

esomeprazole magnesium: Given orally placebo: Given orally

Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)

Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).

acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally

Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)

Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).

acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally


Participant Flow:   Overall Study
    Arm I (Placebo, Esomeprazole Magnesium)     Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)     Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)  
STARTED     30     47     45  
COMPLETED     29     42     43  
NOT COMPLETED     1     5     2  
Protocol Violation                 1                 5                 2  



  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.
Two patients from ARM II withdrew due to an inadequate number of biopsies and were not included in baseline measures.

Reporting Groups
  Description
Arm I (Placebo, Esomeprazole Magnesium)

Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).

esomeprazole magnesium: Given orally placebo: Given orally

Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)

Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).

acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally

Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)

Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).

acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally

Total Total of all reporting groups

Baseline Measures
    Arm I (Placebo, Esomeprazole Magnesium)     Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)     Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)     Total  
Number of Participants  
[units: participants]
  30     45     45     120  
Age  
[units: years]
Median ( Full Range )
  61  
  ( 32 to 86 )  
  59  
  ( 34 to 81 )  
  59  
  ( 35 to 82 )  
  60  
  ( 32 to 86 )  
Gender  
[units: participants]
       
Female     4     8     7     19  
Male     26     37     38     101  
Region of Enrollment  
[units: participants]
       
United States     30     45     45     120  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Mean Tissue Prostaglandin E2 (PGE2) Concentration as Determined From Barrett's Research Mucosal Biopsy Samples   [ Time Frame: Baseline to 30 days after completion of study treatment ]

2.  Secondary:   Toxicity   [ Time Frame: Up to 30 days after completion of study treatment ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Paul J. Limburg, M.D., M.P.H.
Organization: Mayo Clinic Rochester
e-mail: limburg.paul@mayo.edu


No publications provided by National Cancer Institute (NCI)

Publications automatically indexed to this study:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00474903     History of Changes
Other Study ID Numbers: NCI-2009-00838, NCI-2009-00838, MAY04-4-01, CDR0000544180, MAYO-MAY04-4-01, MAY04-4-01, N01CN35000
Study First Received: May 16, 2007
Results First Received: January 8, 2014
Last Updated: June 2, 2014
Health Authority: United States: Food and Drug Administration
United States: Federal Government