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.
First received: May 11, 2011
Last updated: September 14, 2015
Last verified: September 2015
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||May 2008 (Final data collection date for primary outcome measure)
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
aspirin, 100 mg, qd x 8 weeks
Other Name: aspirin protect
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)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- aspirin users who have a peptic ulcer confirmed by endoscopy
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01353144
|Kaohsiung, Taiwan, 807 |
|Kaohsiung Veterans General Hospital
|Kaohsiung, Taiwan, 813 |
Kaohsiung Veterans General Hospital.
||Kwok-Hung Lai, MD
||Kaohsiung Veterans General Hospital.
||Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 11, 2011
|Results First Received:
||September 14, 2015
||September 14, 2015
||Taiwan: Institutional Review Board
Keywords provided by Kaohsiung Veterans General Hospital.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 29, 2016
Digestive System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Proton Pump Inhibitors