A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
1 other identifier
interventional
178
1 country
3
Brief Summary
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2007
Shorter than P25 for phase_4
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 11, 2011
CompletedFirst Posted
Study publicly available on registry
May 12, 2011
CompletedResults Posted
Study results publicly available
October 14, 2015
CompletedNovember 1, 2016
September 1, 2016
11 months
May 11, 2011
September 14, 2015
September 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants in Whom Peptic Ulcer Was Healed
Number of participants in whom peptic ulcer was healed at week 8
8 weeks
Secondary Outcomes (1)
Number of Participants Deveoping Peptic Ulcer Bleeding
8 weeks
Study Arms (2)
esomeprazole
NO INTERVENTIONesomeprazole (40 mg/day) for 8 weeks
esomeprazole plus aspirin
ACTIVE COMPARATOResomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- aspirin users who have a peptic ulcer confirmed by endoscopy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Chung-Ho Hospital
Kaohsiung, Taiwan, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 813, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was performed in a single country
Results Point of Contact
- Title
- Dr. Ping-I Hsu
- Organization
- Kaohsiung Veterans General Hospital
Study Officials
- STUDY CHAIR
Kwok-Hung Lai, MD
Kaohsiung Veterans General Hospital.
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 11, 2011
First Posted
May 12, 2011
Study Start
June 1, 2007
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
November 1, 2016
Results First Posted
October 14, 2015
Record last verified: 2016-09