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

This study has been completed.
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital. Identifier:
First received: May 11, 2011
Last updated: September 12, 2016
Last verified: September 2016
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Condition Intervention Phase
Peptic Ulcer
Drug: aspirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Resource links provided by NLM:

Further study details as provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • Number of Participants Deveoping Peptic Ulcer Bleeding [ Time Frame: 8 weeks ]
    Number of participants deveoping peptic ulcer bleeding during 8-week study period

Enrollment: 178
Study Start Date: June 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: aspirin protect

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01353144

Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Study Chair: Kwok-Hung Lai, MD Kaohsiung Veterans General Hospital.
  More Information

Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital. Identifier: NCT01353144     History of Changes
Other Study ID Numbers: VGHKS96-CT4-26
Study First Received: May 11, 2011
Results First Received: September 14, 2015
Last Updated: September 12, 2016

Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
peptic ulcer

Additional relevant MeSH terms:
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors processed this record on May 25, 2017