Back to resultsA Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Primary Purpose
Peptic Ulcer
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Peptic Ulcer focused on measuring aspirin, peptic ulcer
Eligibility Criteria
Inclusion Criteria:
- aspirin users who have a peptic ulcer confirmed by endoscopy
Exclusion Criteria:
- serious medical illness (including cardiovascular events within 6 months before endoscopy)
- acute gastrointestinal bleeding
- a history of gastric or duodenal surgery
- allergic to the study drugs
- require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents
- pregnancy
Sites / Locations
- Chung-Ho Hospital
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
esomeprazole
esomeprazole plus aspirin
Arm Description
esomeprazole (40 mg/day) for 8 weeks
esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
Outcomes
Primary Outcome Measures
Number of Participants in Whom Peptic Ulcer Was Healed
Number of participants in whom peptic ulcer was healed at week 8
Secondary Outcome Measures
Number of Participants Deveoping Peptic Ulcer Bleeding
Number of participants deveoping peptic ulcer bleeding during 8-week study period
Full Information
NCT ID
NCT01353144
First Posted
May 11, 2011
Last Updated
September 12, 2016
Sponsor
Kaohsiung Veterans General Hospital.
1. Study Identification
Unique Protocol Identification Number
NCT01353144
Brief Title
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Official Title
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Detailed Description
The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers.
Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer
Keywords
aspirin, peptic ulcer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
esomeprazole
Arm Type
No Intervention
Arm Description
esomeprazole (40 mg/day) for 8 weeks
Arm Title
esomeprazole plus aspirin
Arm Type
Active Comparator
Arm Description
esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
Intervention Type
Drug
Intervention Name(s)
aspirin
Other Intervention Name(s)
aspirin protect
Intervention Description
aspirin, 100 mg, qd x 8 weeks
Primary Outcome Measure Information:
Title
Number of Participants in Whom Peptic Ulcer Was Healed
Description
Number of participants in whom peptic ulcer was healed at week 8
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of Participants Deveoping Peptic Ulcer Bleeding
Description
Number of participants deveoping peptic ulcer bleeding during 8-week study period
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
aspirin users who have a peptic ulcer confirmed by endoscopy
Exclusion Criteria:
serious medical illness (including cardiovascular events within 6 months before endoscopy)
acute gastrointestinal bleeding
a history of gastric or duodenal surgery
allergic to the study drugs
require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents
pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwok-Hung Lai, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Study Chair
Facility Information:
Facility Name
Chung-Ho Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
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