Trial Outcomes & Findings for Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers (NCT NCT02551744)

NCT ID: NCT02551744

Last Updated: 2019-08-08

Results Overview

Follow-up endoscopy was performed at the end of the 6th month

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 101 participants
• Primary outcome timeframe: six month
• Results posted on: 2019-08-08

Participant Flow

Participant milestones

Measure	Proton Pump Inhibitor Group Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.	Histamine-2 Receptor Antagonist Group famotidine Tab 40 mg qd for 6 months. histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.
Overall Study STARTED	50	51
Overall Study COMPLETED	50	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers

Baseline characteristics by cohort

Measure	Proton Pump Inhibitor Group n=50 Participants Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.	Histamine-2 Receptor Antagonist Group n=51 Participants famotidine Tab 40 mg qd for 6 months. histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.	Total n=101 Participants Total of all reporting groups
Age, Continuous	73.1 years STANDARD_DEVIATION 11.1 • n=5 Participants	71.8 years STANDARD_DEVIATION 10.9 • n=7 Participants	72.4 years STANDARD_DEVIATION 11.0 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	50 Participants n=5 Participants	51 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Taiwan	50 participants n=5 Participants	51 participants n=7 Participants	101 participants n=5 Participants
history of smoking	3 participants n=5 Participants	4 participants n=7 Participants	7 participants n=5 Participants

PRIMARY outcome

Timeframe: six month

Population: Intention to treat

Follow-up endoscopy was performed at the end of the 6th month

Outcome measures

Measure	Proton Pump Inhibitor Group n=50 Participants Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.	Histamine-2 Receptor Antagonist Group n=51 Participants famotidine Tab 40 mg qd for 6 months. histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.
Number of Participants With Ulcer Recurrence	1 participants	7 participants

Adverse Events

Proton Pump Inhibitor Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Histamine-2 Receptor Antagonist Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Proton Pump Inhibitor Group n=50 participants at risk Pantoprazole Tab 40mg qd for 6 monthrs. proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.	Histamine-2 Receptor Antagonist Group n=51 participants at risk famotidine Tab 40 mg qd for 6 months. histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.
General disorders Abdominal pain	2.0% 1/50 • Number of events 1 • six month	2.0% 1/51 • Number of events 1 • six month

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