A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
This study has been completed.
Sponsor:
Kaohsiung Veterans General Hospital.
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01353144
First received: May 11, 2011
Last updated: September 14, 2015
Last verified: September 2015
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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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01353144
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | May 11, 2011 |
| Results First Received: | September 14, 2015 |
| Last Updated: | September 14, 2015 |
| 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 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 |
ClinicalTrials.gov processed this record on September 23, 2016