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Trial record 53 of 150 for:    tetracycline

Comparison of Two Rescue Therapies for Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT02547012
Recruitment Status : Completed
First Posted : September 11, 2015
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+tetra
Drug: esomeprazole+amox+levo
Enrollment 51
Recruitment Details recruitment period: Oct 2013 - Jul 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 Esomeprazole+Amox+Levo+Tetra Esomeprazole+Amox+Levo
Hide Arm/Group Description

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

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

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.,

Period Title: Overall Study
Started 24 27
Completed 24 27
Not Completed 0 0
Arm/Group Title Esomeprazole+Amox+Levo+Tetra Esomeprazole+Amox+Levo Total
Hide Arm/Group Description

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

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

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.,

Total of all reporting groups
Overall Number of Baseline Participants 24 27 51
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 27 participants 51 participants
57.88  (9.13) 56.44  (15.02) 56.79  (12.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
Female
14
  58.3%
16
  59.3%
30
  58.8%
Male
10
  41.7%
11
  40.7%
21
  41.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
24
 100.0%
27
 100.0%
51
 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 24 participants 27 participants 51 participants
24 27 51
history of smoking  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 27 participants 51 participants
2 2 4
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
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+Tetra Esomeprazole+Amox+Levo
Hide Arm/Group Description:

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

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

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.,

Overall Number of Participants Analyzed 24 27
Measure Type: Number
Unit of Measure: participants
13 21
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Esomeprazole+Amox+Levo+Tetra Esomeprazole+Amox+Levo
Hide Arm/Group Description

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

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

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.,

All-Cause Mortality
Esomeprazole+Amox+Levo+Tetra Esomeprazole+Amox+Levo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/27 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Esomeprazole+Amox+Levo+Tetra Esomeprazole+Amox+Levo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Esomeprazole+Amox+Levo+Tetra Esomeprazole+Amox+Levo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/24 (58.33%)      5/27 (18.52%)    
Gastrointestinal disorders     
Nausea  [1]  12/24 (50.00%)  12 2/27 (7.41%)  2
Nervous system disorders     
Dizziness  [2]  2/24 (8.33%)  2 3/27 (11.11%)  3
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. 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: NCT02547012     History of Changes
Other Study ID Numbers: VGHKS13-CT11-15
First Submitted: September 6, 2015
First Posted: September 11, 2015
Results First Submitted: October 20, 2017
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019