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

• Sponsor: Kaohsiung Veterans General Hospital. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01353144
• Collaborator: (none)
• Enrollment: 178
• Locations: 2
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 89
• Patients Per Site Per Month: 8.1

Study Details

Study Description

Brief Summary

Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Condition or Disease	Intervention/Treatment	Phase
Peptic Ulcer	Drug: aspirin	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 178 participants
• 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
• Study Start Date: Jun 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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 Names: aspirin protect

Outcome Measures

Primary Outcome Measures

1. Number of Participants in Whom Peptic Ulcer Was Healed [8 weeks]

   Number of participants in whom peptic ulcer was healed at week 8

Secondary Outcome Measures

1. Number of Participants Deveoping Peptic Ulcer Bleeding [8 weeks]

   Number of participants deveoping peptic ulcer bleeding during 8-week study period

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Chung-Ho Hospital	Kaohsiung		Taiwan	807
2	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.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.
• ClinicalTrials.gov Identifier: NCT01353144
• Other Study ID Numbers: VGHKS96-CT4-26
• First Posted: May 12, 2011
• Last Update Posted: Nov 1, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Ping-I (William) Hsu, M.D., Professor, Kaohsiung Veterans General Hospital.: aspirin; peptic ulcer
• Additional relevant MeSH terms: Peptic Ulcer; Ulcer; Aspirin

Study Results

Participant Flow

Arm/Group Title	Esomeprazole	Esomeprazole Plus Aspirin
Arm/Group Description	esomeprazole (40 mg/day) for 8 weeks	esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks
Period Title: Overall Study
STARTED	89	89
COMPLETED	80	81
NOT COMPLETED	9	8

Baseline Characteristics

Arm/Group Title	Esomeprazole	Esomeprazole Plus Aspirin	Total
Arm/Group Description	esomeprazole (40 mg/day) for 8 weeks	esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks	Total of all reporting groups
Overall Participants	89	89	178
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	21 23.6%	26 29.2%	47 26.4%
>=65 years	68 76.4%	63 70.8%	131 73.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.0 (11.0)	69.9 (12.4)	69.9 (11.6)
Sex: Female, Male (Count of Participants)
Female	36 40.4%	37 41.6%	73 41%
Male	53 59.6%	52 58.4%	105 59%
Region of Enrollment (participants) [Number]
Taiwan	89 100%	89 100%	178 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants in Whom Peptic Ulcer Was Healed
Description	Number of participants in whom peptic ulcer was healed at week 8
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole	Esomeprazole Plus Aspirin
Arm/Group Description	esomeprazole (40 mg/day) for 8 weeks	esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks
Measure Participants	89	89
Number [participants]	66 74.2%	66 74.2%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Esomeprazole Plus Aspirin	Esomeprazole
Arm/Group Description	esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks	esomeprazole (40 mg/day) for 8 weeks
Measure Participants	89	89
Number [participants]	0 0%	0 0%

Adverse Events

Arm/Group Title	Esomeprazole		Esomeprazole Plus Aspirin
Arm/Group Description	esomeprazole (40 mg/day) for 8 weeks		esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks
All Cause Mortality
	Esomeprazole		Esomeprazole Plus Aspirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Esomeprazole		Esomeprazole Plus Aspirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/89 (0%)		0/89 (0%)
Other (Not Including Serious) Adverse Events
	Esomeprazole		Esomeprazole Plus Aspirin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/89 (1.1%)		2/89 (2.2%)
Gastrointestinal disorders
persistent dyspepsia	0/89 (0%)	0	1/89 (1.1%)	1
diarrhea	0/89 (0%)	0	1/89 (1.1%)	1
Skin and subcutaneous tissue disorders
skin rash	1/89 (1.1%)	1	0/89 (0%)	0

Limitations/Caveats

The trial was performed in a single country

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.