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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01353144

First Posted: May 12, 2011

Last Update Posted: November 1, 2016

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Information provided by (Responsible Party):

Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

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 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

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Aspirin Esomeprazole

U.S. FDA Resources

Further study details as provided by Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	178
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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

Information from the National Library of Medicine

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

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
First Submitted:	May 11, 2011
First Posted:	May 12, 2011
Results First Submitted:	September 14, 2015
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

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