A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
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ClinicalTrials.gov Identifier: NCT01353144 |
Recruitment Status
:
Completed
First Posted
: May 12, 2011
Results First Posted
: October 14, 2015
Last Update Posted
: November 1, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Peptic Ulcer | Drug: aspirin | Phase 4 |
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 (Clinical Trial) |
Actual Enrollment : | 178 participants |
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 |
Study Start Date : | June 2007 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |

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 Name: aspirin protect
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- 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
- Number of Participants Deveoping Peptic Ulcer Bleeding [ Time Frame: 8 weeks ]Number of participants deveoping peptic ulcer bleeding during 8-week study period

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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

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
Taiwan | |
Chung-Ho Hospital | |
Kaohsiung, Taiwan, 807 | |
Kaohsiung Veterans General Hospital | |
Kaohsiung, Taiwan, 813 |
Study Chair: | Kwok-Hung Lai, MD | Kaohsiung Veterans General Hospital. |
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 Posted: | May 12, 2011 Key Record Dates |
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 |