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Trial record 63 of 201 for:    TETRACYCLINE

Comparing the Efficacy of Reverse Hybrid Therapy and Bismuth Quadruple Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02547038
Recruitment Status : Completed
First Posted : September 11, 2015
Results First Posted : June 10, 2019
Last Update Posted : June 10, 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: Single (Investigator);   Primary Purpose: Treatment
Condition Helicobacter Pylori Infection
Interventions Drug: pantoprazole+bismuth+tetra+metro
Drug: (panto+amox+clar+metr)+(panto+amox)
Enrollment 352
Recruitment Details recruitment period: August 2015 through February 2017. Type of location: Kaohsiung Veterans General Hospital and Kaohsiung Medical University Chung-Ho Memorial Hospital
Pre-assignment Details None were excluded following participant enrollment.
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox)
Hide Arm/Group Description

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Period Title: Overall Study
Started 176 176
Completed 173 174
Not Completed 3 2
Reason Not Completed
Lost to Follow-up             3             2
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox) Total
Hide Arm/Group Description

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Total of all reporting groups
Overall Number of Baseline Participants 176 176 352
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 352 participants
<=18 years 0 0 0
Between 18 and 65 years 145 137 282
>=65 years 31 39 70
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants 176 participants 352 participants
53.8  (12.1) 54.5  (12.9) 54.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 352 participants
Female
97
  55.1%
87
  49.4%
184
  52.3%
Male
79
  44.9%
89
  50.6%
168
  47.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 352 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
176
 100.0%
176
 100.0%
352
 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 176 participants 176 participants 352 participants
176 176 352
History of smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants 176 participants 352 participants
24 35 59
1.Primary Outcome
Title Number of Participants in Which H. Pylori Was Eradicated
Hide Description Evaluate eradication outcome by endoscopy urease test and histology or urea breath test (Number of Participants With Complete Eradication of Helicobacter Pylori)
Time Frame sixth week after the end of anti- H. pylori therapy
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox)
Hide Arm/Group Description:

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

Overall Number of Participants Analyzed 176 176
Measure Type: Number
Unit of Measure: participants
169 170
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox)
Hide Arm/Group Description

pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days

a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

(panto+amox+clar+metr)+(panto+amox): a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily

All-Cause Mortality
Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/176 (0.00%)      0/176 (0.00%)    
Hide Serious Adverse Events
Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/176 (0.00%)      0/176 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Pantoprazole+Bismuth+Tetra+Metro (Panto+Amox+Clar+Metr)+(Panto+Amox)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   86/176 (48.86%)      33/176 (18.75%)    
Gastrointestinal disorders     
Abdominal pain  [1]  5/176 (2.84%)  5 7/176 (3.98%)  7
Diarrhea  [1]  1/176 (0.57%)  1 7/176 (3.98%)  7
General disorders     
Nausea  [2]  67/176 (38.07%)  67 15/176 (8.52%)  15
Dizziness  [1]  13/176 (7.39%)  13 4/176 (2.27%)  4
Indicates events were collected by systematic assessment
[1]
Patients had dizziness discomforts.
[2]
Patients had Nausea discomforts.
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: NCT02547038    
Other Study ID Numbers: VGHKS15-CT2-10
First Submitted: September 6, 2015
First Posted: September 11, 2015
Results First Submitted: October 30, 2018
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019