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A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01353144
First received: May 11, 2011
Last updated: September 14, 2015
Last verified: September 2015
Results First Received: September 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Peptic Ulcer
Intervention: Drug: aspirin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Esomeprazole esomeprazole (40 mg/day) for 8 weeks
Esomeprazole Plus Aspirin

esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks

aspirin: aspirin, 100 mg, qd x 8 weeks


Participant Flow:   Overall Study
    Esomeprazole     Esomeprazole Plus Aspirin  
STARTED     89     89  
COMPLETED     80     81  
NOT COMPLETED     9     8  



  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.
No text entered.

Reporting Groups
  Description
Esomeprazole esomeprazole (40 mg/day) for 8 weeks
Esomeprazole Plus Aspirin

esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks

aspirin: aspirin, 100 mg, qd x 8 weeks

Total Total of all reporting groups

Baseline Measures
    Esomeprazole     Esomeprazole Plus Aspirin     Total  
Number of Participants  
[units: participants]
  89     89     178  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     21     26     47  
>=65 years     68     63     131  
Age  
[units: years]
Mean (Standard Deviation)
  70.0  (11.0)     69.9  (12.4)     69.9  (11.6)  
Gender  
[units: participants]
     
Female     36     37     73  
Male     53     52     105  
Region of Enrollment  
[units: participants]
     
Taiwan     89     89     178  



  Outcome Measures

1.  Primary:   Rate of Ulcer Healing   [ Time Frame: 8 weeks ]

2.  Secondary:   Rate of Peptic Ulcer Bleeding   [ Time Frame: 8 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
The trial was performed in a single country


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Ping-I Hsu
Organization: Kaohsiung Veterans General Hospital
phone: +886-7-3422121 ext 8233
e-mail: pihsu@vghks.gov.tw



Responsible Party: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01353144     History of Changes
Other Study ID Numbers: VGHKS96-CT4-26
Study First Received: May 11, 2011
Results First Received: September 14, 2015
Last Updated: September 14, 2015
Health Authority: Taiwan: Institutional Review Board