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Trial record 62 of 214 for:    TETRACYCLINE

Comparison of Hybrid and Bismuth Quadruple Therapies for Helicobacter Pylori Eradication

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ClinicalTrials.gov Identifier: NCT02541864
Recruitment Status : Completed
First Posted : September 4, 2015
Results First Posted : August 10, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Feng-Woei Tsay, Kaohsiung Veterans General Hospital.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Helicobacter Pylori Infection
Interventions Drug: Bismuth quadruple therapy
Drug: Hybrid therapy
Enrollment 330
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro Hybrid Therapy
Hide Arm/Group Description

pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days

a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Period Title: Overall Study
Started 164 166
Completed 164 166
Not Completed 0 0
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro Hybrid Therapy Total
Hide Arm/Group Description

pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days

a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Total of all reporting groups
Overall Number of Baseline Participants 164 166 330
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 166 participants 330 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
134
  81.7%
136
  81.9%
270
  81.8%
>=65 years
30
  18.3%
30
  18.1%
60
  18.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 166 participants 330 participants
53.46  (12.28) 54.48  (11.45) 53.97  (11.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 166 participants 330 participants
Female
70
  42.7%
87
  52.4%
157
  47.6%
Male
94
  57.3%
79
  47.6%
173
  52.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Taiwan Number Analyzed 164 participants 166 participants 330 participants
164
 100.0%
166
 100.0%
330
 100.0%
1.Primary Outcome
Title Number of Participants in Which H. Pylori Was Eradicated
Hide Description Repeated endoscopy with rapid urease test, histological examination and culture or urea breath tests are conducted to assess H. pylori status.
Time Frame at the 6th 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 Hybrid Therapy
Hide Arm/Group Description:

pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days

a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Overall Number of Participants Analyzed 164 166
Measure Type: Number
Unit of Measure: participants
154 154
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pantoprazole+Bismuth+Tetra+Metro Hybrid Therapy
Hide Arm/Group Description

pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, metronidazole 250 mg qid for 14 days

pantoprazole+bismuth+tetra+metro: pantoprazole 40 mg bid , bismuth subcitrate 120 mg qid., tetracycline 500 mg qid, and metronidazole 250 mg qid for 14 days

a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

Hybrid therapy: a dual therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid for 7 days, followed by a quadruple therapy with pantoprazole 40 mg bid, amoxicillin 1 g bid, clarithromycin 500 mg bid, and metronidazole 500 mg bid for a further 7 days

All-Cause Mortality
Pantoprazole+Bismuth+Tetra+Metro Hybrid Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pantoprazole+Bismuth+Tetra+Metro Hybrid Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/164 (0.00%)      0/166 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pantoprazole+Bismuth+Tetra+Metro Hybrid Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   92/164 (56.10%)      19/166 (11.45%)    
Gastrointestinal disorders     
Nausea  [1]  75/164 (45.73%)  75 12/166 (7.23%)  12
Dizziness  [2]  17/164 (10.37%)  17 7/166 (4.22%)  7
Indicates events were collected by systematic assessment
[1]
Patients had Nausea discomforts.
[2]
Patients had dizziness 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. Feng-Woei Tsay
Organization: Kaohsiung Veterans General Hospital
Phone: +886-7-3422121 ext 8233
EMail: fwchaie@vghks.gov.tw
Publications:
Layout table for additonal information
Responsible Party: Feng-Woei Tsay, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT02541864     History of Changes
Other Study ID Numbers: VGHKS12-CT11-08
First Submitted: August 31, 2015
First Posted: September 4, 2015
Results First Submitted: July 12, 2017
Results First Posted: August 10, 2017
Last Update Posted: November 24, 2017