Trial Outcomes & Findings for A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers (NCT NCT01353144)

NCT ID: NCT01353144

Last Updated: 2016-11-01

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 178 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2016-11-01

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Esomeprazole n=89 Participants esomeprazole (40 mg/day) for 8 weeks	Esomeprazole Plus Aspirin n=89 Participants esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks	Total n=178 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	26 Participants n=7 Participants	47 Participants n=5 Participants
Age, Categorical >=65 years	68 Participants n=5 Participants	63 Participants n=7 Participants	131 Participants n=5 Participants
Age, Continuous	70.0 years STANDARD_DEVIATION 11.0 • n=5 Participants	69.9 years STANDARD_DEVIATION 12.4 • n=7 Participants	69.9 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants	37 Participants n=7 Participants	73 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants	52 Participants n=7 Participants	105 Participants n=5 Participants
Region of Enrollment Taiwan	89 participants n=5 Participants	89 participants n=7 Participants	178 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Esomeprazole n=89 Participants esomeprazole (40 mg/day) for 8 weeks	Esomeprazole Plus Aspirin n=89 Participants esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks
Number of Participants in Whom Peptic Ulcer Was Healed	66 participants	66 participants

SECONDARY outcome

Timeframe: 8 weeks

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

Outcome measures

Measure	Esomeprazole n=89 Participants esomeprazole (40 mg/day) for 8 weeks	Esomeprazole Plus Aspirin n=89 Participants esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks
Number of Participants Deveoping Peptic Ulcer Bleeding	0 participants	0 participants

Adverse Events

Esomeprazole

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Esomeprazole Plus Aspirin

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Esomeprazole n=89 participants at risk esomeprazole (40 mg/day) for 8 weeks	Esomeprazole Plus Aspirin n=89 participants at risk esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks aspirin: aspirin, 100 mg, qd x 8 weeks
Skin and subcutaneous tissue disorders skin rash	1.1% 1/89 • Number of events 1	0.00% 0/89
Gastrointestinal disorders persistent dyspepsia	0.00% 0/89	1.1% 1/89 • Number of events 1
Gastrointestinal disorders diarrhea	0.00% 0/89	1.1% 1/89 • Number of events 1

Additional Information

Dr. Ping-I Hsu

Kaohsiung Veterans General Hospital

Phone: +886-7-3422121

Email: pihsu@vghks.gov.tw

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place