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Trial record 21 of 214 for:    TETRACYCLINE

Levofloxacin Triple and Bismuth Quadruple Therapies for Rescue Treatment of H Pylori Infection

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ClinicalTrials.gov Identifier: NCT02978157
Recruitment Status : Completed
First Posted : November 30, 2016
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
Kaohsiung Medical University Chung-Ho Memorial Hospital
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: None (Open Label);   Primary Purpose: Treatment
Condition Helicobacter Pylori Infection
Interventions Drug: esomeprazole+amox+levo
Drug: esomeprazole+bismuth+tetra+levo
Enrollment 102
Recruitment Details
  1. recruitment period: February 2015
  2. 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 Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo
Hide Arm/Group Description

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Period Title: Overall Study
Started 52 50
Completed 52 50
Not Completed 0 0
Arm/Group Title Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo Total
Hide Arm/Group Description

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Total of all reporting groups
Overall Number of Baseline Participants 52 50 102
Hide Baseline Analysis Population Description
Patients received levoflaxacin triple therapy
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 102 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
39
  75.0%
40
  80.0%
79
  77.5%
>=65 years
13
  25.0%
10
  20.0%
23
  22.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 50 participants 102 participants
55.08  (13.55) 56.38  (12.81) 55.72  (13.14)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 102 participants
Female
35
  67.3%
25
  50.0%
60
  58.8%
Male
17
  32.7%
25
  50.0%
42
  41.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 102 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
52
 100.0%
50
 100.0%
102
 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 52 participants 50 participants 102 participants
52 50 102
history of smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 102 participants
4 4 8
1.Primary Outcome
Title Number of Participants in Which H. Pylori Was Eradicated
Hide Description Number of participants with negative H pylori status in follow-up tests as a measure of successful eradication
Time Frame six weeks after the end of anti-H pylori therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat
Arm/Group Title Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo
Hide Arm/Group Description:

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

Overall Number of Participants Analyzed 52 50
Measure Type: Number
Unit of Measure: participants
36 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Esomeprazole+Amox+Levo, Esomeprazole+Bismuth+Tetra+Levo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo
Hide Arm/Group Description

esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+amox+levo: esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.

esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

esomeprazole+bismuth+tetra+levo: esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.

All-Cause Mortality
Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)      0/50 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/52 (0.00%)      0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Esomeprazole+Amox+Levo Esomeprazole+Bismuth+Tetra+Levo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/52 (11.54%)      11/50 (22.00%)    
Gastrointestinal disorders     
Nausea   4/52 (7.69%)  4 8/50 (16.00%)  8
Dizziness   2/52 (3.85%)  2 3/50 (6.00%)  3
Indicates events were collected by systematic assessment
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: NCT02978157     History of Changes
Other Study ID Numbers: VGHKS104-062
First Submitted: November 28, 2016
First Posted: November 30, 2016
Results First Submitted: October 20, 2017
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019