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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01353144
First Posted: May 12, 2011
Last Update Posted: November 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
  Purpose
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: None (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.

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01353144


Locations
Taiwan
Chung-Ho Hospital
Kaohsiung, Taiwan, 807
Kaohsiung Veterans General Hospital
Kaohsiung, Taiwan, 813
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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.
ClinicalTrials.gov Identifier: NCT01353144     History of Changes
Other Study ID Numbers: VGHKS96-CT4-26
First Submitted: May 11, 2011
First Posted: May 12, 2011
Results First Submitted: September 14, 2015
Results First Posted: October 14, 2015
Last Update Posted: November 1, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Aspirin
Esomeprazole
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors