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

NCT ID: NCT01353144

Last Updated: 2016-11-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-05-31

Brief Summary

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Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Detailed Description

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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

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Peptic Ulcer

Keywords

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aspirin peptic ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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esomeprazole

esomeprazole (40 mg/day) for 8 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

esomeprazole plus aspirin

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

Group Type ACTIVE_COMPARATOR

aspirin

Intervention Type DRUG

aspirin, 100 mg, qd x 8 weeks

Interventions

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aspirin

aspirin, 100 mg, qd x 8 weeks

Intervention Type DRUG

Other Intervention Names

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aspirin protect

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Ping-I (William) Hsu, M.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kwok-Hung Lai, MD

Role: STUDY_CHAIR

Kaohsiung Veterans General Hospital.

Locations

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Chung-Ho Hospital

Kaohsiung, Taiwan, Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung, Taiwan, Taiwan

Site Status

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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VGHKS96-CT4-26

Identifier Type: -

Identifier Source: org_study_id