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Sequential and Hybrid Therapies for H Pylori Infection

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ClinicalTrials.gov Identifier: NCT01085786
Recruitment Status : Completed
First Posted : March 12, 2010
Results First Posted : May 6, 2011
Last Update Posted : September 21, 2015
Sponsor:
Collaborators:
Baylor College of Medicine
Kaohsiung Medical University
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: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Helicobacter Pylori Infection
Interventions Drug: 14-day sequential treatment
Drug: 14-day hybrid treatment
Enrollment 240
Recruitment Details recruitment period: Aug 2008 - May 2010
Pre-assignment Details no significant events for the overall study
Arm/Group Title 14-day Sequential Treatment 14-day Hybrid Treatment
Hide Arm/Group Description One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Period Title: Overall Study
Started 123 117
Completed 123 117
Not Completed 0 0
Arm/Group Title 14-day Sequential Treatment 14-day Hybrid Treatment Total
Hide Arm/Group Description One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 123 117 240
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 117 participants 240 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
97
  78.9%
91
  77.8%
188
  78.3%
>=65 years
26
  21.1%
26
  22.2%
52
  21.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 117 participants 240 participants
55.1  (11.8) 54.3  (11.4) 54.7  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 117 participants 240 participants
Female
62
  50.4%
58
  49.6%
120
  50.0%
Male
61
  49.6%
59
  50.4%
120
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 123 participants 117 participants 240 participants
123 117 240
1.Primary Outcome
Title Number of Participants in Which H. Pylori Was Eradicated
Hide Description evaluate eradication outcome by endoscopy with urease test or urea breath test
Time Frame Dec 2010
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 14-day Sequential Treatment 14-day Hybrid Treatment
Hide Arm/Group Description:
One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
Overall Number of Participants Analyzed 123 117
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
94
(90 to 98)
99
(95 to 100)
2.Secondary Outcome
Title Adverse Events
Hide Description by standardized questionnaire
Time Frame Dec 2010
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Compliance Rate
Hide Description Good compliance is defined as taking equal or more than 90% of eradication medicines
Time Frame Dec 2010
Outcome Measure Data Not Reported
Time Frame period of data collection: 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 14-day Sequential Treatment 14-day Hybrid Treatment
Hide Arm/Group Description One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days. esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
All-Cause Mortality
14-day Sequential Treatment 14-day Hybrid Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
14-day Sequential Treatment 14-day Hybrid Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/123 (0.00%)      0/117 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
14-day Sequential Treatment 14-day Hybrid Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/123 (21.14%)      17/117 (14.53%)    
Gastrointestinal disorders     
Taste perversion  1  11/123 (8.94%)  11 8/117 (6.84%)  8
nausea  1  13/123 (10.57%)  13 3/117 (2.56%)  3
diarrhea  1  4/123 (3.25%)  4 8/117 (6.84%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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: 886-7-3462121 ext 8233
EMail: pihsu@isca.vghks.gov.tw
Layout table for additonal information
Responsible Party: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT01085786    
Other Study ID Numbers: VGHKS97-CT6-08
First Submitted: March 11, 2010
First Posted: March 12, 2010
Results First Submitted: April 12, 2011
Results First Posted: May 6, 2011
Last Update Posted: September 21, 2015