Peptic UlcerPhase 4NCT01353144
A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
A Phase 4 study testing aspirin in people with Peptic Ulcer, run by Kaohsiung Veterans General Hospital. at 3 sites in Taiwan.
Trial summary
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 3 sitesTaiwan
- Study dates
- Jun 2007to May 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aspirin users who have a peptic ulcer confirmed by endoscopy
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Kaohsiung Veterans General Hospital
Kaohsiung City, 813
About this study
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Read the 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.
- Conditions
- Peptic Ulcer
- Being tested
- aspirin
- Keywords
- aspirin, peptic ulcer
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aspirinDrug
Also called aspirin protect
aspirin, 100 mg, qd x 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| esomeprazole | No intervention | esomeprazole (40 mg/day) for 8 weeks |
| esomeprazole plus aspirin | Active comparator | esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks Receives: Drug: aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants in Whom Peptic Ulcer Was Healed
Number of participants in whom peptic ulcer was healed at week 8
Measured: 8 weeks
Secondary outcomes (1)
Number of Participants Deveoping Peptic Ulcer Bleeding
Number of participants deveoping peptic ulcer bleeding during 8-week study period
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2011 (estimated)
- Study startJun 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peptic UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Veterans General Hospital.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
- Investigators
- Kwok-Hung Lai, MD, Study chair, Kaohsiung Veterans General Hospital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353144
- Sponsor's protocol ID
- VGHKS96-CT4-26
- Status last verified
- Sep 2016
- First submitted
- 11 May 2011
- Last updated
- 1 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
- ClinicalTrials.gov ID
- NCT01353144
- Acronym / sponsor ID
- VGHKS96-CT4-26
- Conditions
- Peptic Ulcer
- Keywords
- aspirin, peptic ulcer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Kaohsiung Veterans General Hospital.University, hospital or other
- Study start
- Jun 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 May 2011 (estimated)
- Results
- Posted 14 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| esomeprazole | No intervention | –esomeprazole (40 mg/day) for 8 weeks |
| esomeprazole plus aspirin | Active comparator | Drug: aspirinesomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aspirin users who have a peptic ulcer confirmed by endoscopy
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aspirinAlso: aspirin protectaspirin, 100 mg, qd x 8 weeks | Drug | esomeprazole plus aspirin |
Primary outcome
Number of Participants in Whom Peptic Ulcer Was Healed
Time frame: 8 weeks
Number of participants in whom peptic ulcer was healed at week 8
1 secondary outcome
Number of Participants Deveoping Peptic Ulcer Bleeding
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kwok-Hung Lai, MD study chair
Kaohsiung Veterans General Hospital.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aspirin in people with Peptic Ulcer, run by Kaohsiung Veterans General Hospital. at 3 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants in Whom Peptic Ulcer Was Healed (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2016.