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

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:

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Aspirin Esomeprazole

U.S. FDA Resources

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
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

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

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

No publications provided


Responsible Party:	PING-I HSU/Dr., Kaohsiung Veterans General Hospital
ClinicalTrials.gov Identifier:	NCT01353144 History of Changes
Other Study ID Numbers:	VGHKS96-CT4-26
Study First Received:	May 11, 2011
Last Updated:	May 31, 2011
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Veterans General Hospital.:


aspirin peptic ulcer

Additional relevant MeSH terms:


Peptic Ulcer Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Stomach Diseases Aspirin Esomeprazole Analgesics Analgesics, Non-Narcotic Anti-Inflammatory Agents Anti-Inflammatory Agents, Non-Steroidal Anti-Ulcer Agents	Antipyretics Antirheumatic Agents Cardiovascular Agents Central Nervous System Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Fibrin Modulating Agents Fibrinolytic Agents Gastrointestinal Agents Hematologic Agents Molecular Mechanisms of Pharmacological Action Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 27, 2015