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 12, 2016
Last verified: September 2016
Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
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)
|Sexes 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
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
|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 12, 2016
Keywords provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 27, 2017
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