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

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ClinicalTrials.gov Identifier: NCT02551744
Recruitment Status : Completed
First Posted : September 16, 2015
Results First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Peptic Ulcer
Interventions Drug: histamine-2 receptor antagonist group
Drug: proton pump inhibitor group
Enrollment 101
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group
Hide Arm/Group Description

Pantoprazole Tab 40mg qd for 6 monthrs.

proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.

famotidine Tab 40 mg qd for 6 months.

histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.

Period Title: Overall Study
Started 50 51
Completed 50 51
Not Completed 0 0
Arm/Group Title Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group Total
Hide Arm/Group Description

Pantoprazole Tab 40mg qd for 6 monthrs.

proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.

famotidine Tab 40 mg qd for 6 months.

histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.

Total of all reporting groups
Overall Number of Baseline Participants 50 51 101
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 51 participants 101 participants
73.1  (11.1) 71.8  (10.9) 72.4  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
Female
13
  26.0%
10
  19.6%
23
  22.8%
Male
37
  74.0%
41
  80.4%
78
  77.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
50
 100.0%
51
 100.0%
101
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 50 participants 51 participants 101 participants
50 51 101
history of smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants 51 participants 101 participants
3 4 7
1.Primary Outcome
Title Number of Participants With Ulcer Recurrence
Hide Description Follow-up endoscopy was performed at the end of the 6th month
Time Frame six month
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group
Hide Arm/Group Description:

Pantoprazole Tab 40mg qd for 6 monthrs.

proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.

famotidine Tab 40 mg qd for 6 months.

histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.

Overall Number of Participants Analyzed 50 51
Measure Type: Number
Unit of Measure: participants
1 7
Time Frame six month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group
Hide Arm/Group Description

Pantoprazole Tab 40mg qd for 6 monthrs.

proton pump inhibitor group: pantoprazole tab 40 mg qd for 6 months.

famotidine Tab 40 mg qd for 6 months.

histamine-2 receptor antagonist group: famotidine tab 40 mg qd for 6 months.

All-Cause Mortality
Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)      0/51 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/50 (0.00%)      0/51 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Proton Pump Inhibitor Group Histamine-2 Receptor Antagonist Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/50 (2.00%)      1/51 (1.96%)    
General disorders     
Abdominal pain  [1]  1/50 (2.00%)  1 1/51 (1.96%)  1
Indicates events were collected by systematic assessment
[1]
abdominal pain sufficient to interfere with daily life
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ping-I Hsu
Organization: Kaohsiung Veterans General Hospital
Phone: +886-7-3422121 ext 8233
EMail: pihsu@vghks.gov.tw
Publications:
Layout table for additonal information
Responsible Party: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02551744     History of Changes
Other Study ID Numbers: VGHKS12-CT7-08
First Submitted: September 14, 2015
First Posted: September 16, 2015
Results First Submitted: October 30, 2018
Results First Posted: August 8, 2019
Last Update Posted: August 8, 2019