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

This study has been completed.
Sponsor:
Information provided by:
Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01353144
First received: May 11, 2011
Last updated: May 31, 2011
Last verified: January 2008
  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
Endpoint Classification: Efficacy Study
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 Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:
  • rate of ulcer healing [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    ulcer healing rate at week 8


Secondary Outcome Measures:
  • rate of peptic ulcer bleeding [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    rate of peptic ulcer bleeding within 8-week study period


Enrollment: 232
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353144

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

No publications provided

Responsible Party: PING-I HSU/Dr., Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier: NCT01353144     History of Changes
Other Study ID Numbers: VGHKS96-CT4-26
Study First Received: May 11, 2011
Last Updated: May 31, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 22, 2014