Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01353144
Recruitment Status : Completed
First Posted : May 12, 2011
Results First Posted : October 14, 2015
Last Update Posted : November 1, 2016
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peptic Ulcer
Intervention Drug: aspirin
Enrollment 178
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Esomeprazole Esomeprazole Plus Aspirin
Hide Arm/Group Description esomeprazole (40 mg/day) for 8 weeks

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

aspirin: aspirin, 100 mg, qd x 8 weeks

Period Title: Overall Study
Started 89 89
Completed 80 81
Not Completed 9 8
Arm/Group Title Esomeprazole Esomeprazole Plus Aspirin Total
Hide Arm/Group Description esomeprazole (40 mg/day) for 8 weeks

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

aspirin: aspirin, 100 mg, qd x 8 weeks

Total of all reporting groups
Overall Number of Baseline Participants 89 89 178
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 89 participants 178 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  23.6%
26
  29.2%
47
  26.4%
>=65 years
68
  76.4%
63
  70.8%
131
  73.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 89 participants 178 participants
70.0  (11.0) 69.9  (12.4) 69.9  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 89 participants 178 participants
Female
36
  40.4%
37
  41.6%
73
  41.0%
Male
53
  59.6%
52
  58.4%
105
  59.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 89 participants 89 participants 178 participants
89 89 178
1.Primary Outcome
Title Number of Participants in Whom Peptic Ulcer Was Healed
Hide Description Number of participants in whom peptic ulcer was healed at week 8
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Esomeprazole Plus Aspirin
Hide Arm/Group Description:
esomeprazole (40 mg/day) for 8 weeks

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

aspirin: aspirin, 100 mg, qd x 8 weeks

Overall Number of Participants Analyzed 89 89
Measure Type: Number
Unit of Measure: participants
66 66
2.Secondary Outcome
Title Number of Participants Deveoping Peptic Ulcer Bleeding
Hide Description Number of participants deveoping peptic ulcer bleeding during 8-week study period
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Esomeprazole Plus Aspirin Esomeprazole
Hide Arm/Group Description:

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

aspirin: aspirin, 100 mg, qd x 8 weeks

esomeprazole (40 mg/day) for 8 weeks
Overall Number of Participants Analyzed 89 89
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole Esomeprazole Plus Aspirin
Hide Arm/Group Description esomeprazole (40 mg/day) for 8 weeks

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

aspirin: aspirin, 100 mg, qd x 8 weeks

All-Cause Mortality
Esomeprazole Esomeprazole Plus Aspirin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Esomeprazole Esomeprazole Plus Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/89 (0.00%)      0/89 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.3%
Esomeprazole Esomeprazole Plus Aspirin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/89 (1.12%)      2/89 (2.25%)    
Gastrointestinal disorders     
persistent dyspepsia   0/89 (0.00%)  0 1/89 (1.12%)  1
diarrhea   0/89 (0.00%)  0 1/89 (1.12%)  1
Skin and subcutaneous tissue disorders     
skin rash   1/89 (1.12%)  1 0/89 (0.00%)  0
Indicates events were collected by systematic assessment
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
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
First Submitted: May 11, 2011
First Posted: May 12, 2011
Results First Submitted: September 14, 2015
Results First Posted: October 14, 2015
Last Update Posted: November 1, 2016