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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 12, 2016
Last verified: September 2016
Results First Received: September 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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
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1.  Primary:   Number of Participants in Whom Peptic Ulcer Was Healed   [ Time Frame: 8 weeks ]

2.  Secondary:   Number of Participants Deveoping Peptic Ulcer Bleeding   [ Time Frame: 8 weeks ]


  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 12, 2016