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

September 12, 2016 updated by: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital
      • Kaohsiung, Taiwan, 807
        • Chung-Ho Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: esomeprazole
esomeprazole (40 mg/day) for 8 weeks
ACTIVE_COMPARATOR: esomeprazole plus aspirin
esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
Drug: aspirin
aspirin, 100 mg, qd x 8 weeks
Other Names:
  • aspirin protect

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Deveoping Peptic Ulcer Bleeding
Time Frame: 8 weeks
Number of participants deveoping peptic ulcer bleeding during 8-week study period
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Investigators

  • Study Chair: Kwok-Hung Lai, MD, Kaohsiung Veterans General Hospital.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (ACTUAL)

May 1, 2008

Study Completion (ACTUAL)

May 1, 2008

Study Registration Dates

First Submitted

May 11, 2011

First Submitted That Met QC Criteria

May 11, 2011

First Posted (ESTIMATE)

May 12, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS96-CT4-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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