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Trial record 81 of 201 for:    TETRACYCLINE

Compare Sequential and Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

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: NCT02159976
Recruitment Status : Completed
First Posted : June 10, 2014
Results First Posted : May 13, 2019
Last Update Posted : May 13, 2019
Sponsor:
Collaborators:
SK Chemicals Co., Ltd.
Chong Kun Dang Pharmaceutical
CJ HealthCare Corporation
Green Cross Corporation
Information provided by (Responsible Party):
Nayoung Kim, Seoul National University Bundang 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: Pantoprazole
Drug: Amoxicillin
Drug: Clarithromycin
Drug: Metronidazole
Drug: Tetracycline
Drug: Bismuth
Enrollment 390
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequential Therapy Modified Bismuth Quadruple Therapy
Hide Arm/Group Description

pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)

Pantoprazole

Amoxicillin

Clarithromycin

Metronidazole

pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Pantoprazole

Amoxicillin

Tetracycline

Bismuth

Period Title: Overall Study
Started 195 195
Completed 165 170
Not Completed 30 25
Arm/Group Title Sequential Therapy Modified Bismuth Quadruple Therapy Total
Hide Arm/Group Description

pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)

Pantoprazole

Amoxicillin

Clarithromycin

Metronidazole

pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Pantoprazole

Amoxicillin

Tetracycline

Bismuth

Total of all reporting groups
Overall Number of Baseline Participants 195 195 390
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 195 participants 390 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
154
  79.0%
150
  76.9%
304
  77.9%
>=65 years
41
  21.0%
45
  23.1%
86
  22.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 195 participants 195 participants 390 participants
53.1  (12.6) 53.6  (13.2) 53.4  (12.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 195 participants 195 participants 390 participants
Female
92
  47.2%
78
  40.0%
170
  43.6%
Male
103
  52.8%
117
  60.0%
220
  56.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 195 participants 195 participants 390 participants
195 195 390
1.Primary Outcome
Title Counts of Participants With Successful H. Pylori Eradication
Hide Description [Not Specified]
Time Frame 4 weeks after termination of eradication therapy, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sequential Therapy Modified Bismuth Quadruple Therapy
Hide Arm/Group Description:

pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)

Pantoprazole

Amoxicillin

Clarithromycin

Metronidazole

pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Pantoprazole

Amoxicillin

Tetracycline

Bismuth

Overall Number of Participants Analyzed 195 195
Measure Type: Count of Participants
Unit of Measure: Participants
146
  74.9%
134
  68.7%
2.Secondary Outcome
Title Counts of Participants Whose Drug Compliance is More Than 85%
Hide Description [Not Specified]
Time Frame 4 weeks after termination of eradication therapy, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sequential Therapy Modified Bismuth Quadruple Therapy
Hide Arm/Group Description:

pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)

Pantoprazole

Amoxicillin

Clarithromycin

Metronidazole

pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Pantoprazole

Amoxicillin

Tetracycline

Bismuth

Overall Number of Participants Analyzed 176 177
Measure Type: Count of Participants
Unit of Measure: Participants
165
  93.8%
170
  96.0%
3.Secondary Outcome
Title Counts of Participants With Adverse Event
Hide Description [Not Specified]
Time Frame 4 weeks after termination of eradication therapy, up to 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sequential Therapy Modified Bismuth Quadruple Therapy
Hide Arm/Group Description:

pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)

Pantoprazole

Amoxicillin

Clarithromycin

Metronidazole

pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Pantoprazole

Amoxicillin

Tetracycline

Bismuth

Overall Number of Participants Analyzed 195 195
Measure Type: Count of Participants
Unit of Measure: Participants
93
  47.7%
72
  36.9%
4.Secondary Outcome
Title Functional Dyspepsia Symptom Responses Rate
Hide Description [Not Specified]
Time Frame 1 year after termination of eradication therapy
Hide Outcome Measure Data
Hide Analysis Population Description
SQT and PBAT were used for the initial treatment. Thereafter, treatment success and treatment failure group were divided. In the treatment failure group, secondary treatment was performed. Secondary endpoints were functional and dyspepsia symptom responses rate after successful treatment, not success in both treatment groups.
Arm/Group Title In Eradication Success Group In Eradication Failure Group
Hide Arm/Group Description:
functional dyspepsia symptom responses rate in eradication success group
functional dyspepsia symptom responses rate in eradication failure group
Overall Number of Participants Analyzed 60 3
Measure Type: Count of Participants
Unit of Measure: Participants
complete (≥75%)
44
  73.3%
0
   0.0%
Satisfactory (50-74%)
1
   1.7%
0
   0.0%
Partial (25-49%)
6
  10.0%
1
  33.3%
Refractory (<25%)
9
  15.0%
2
  66.7%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sequential Therapy Modified Bismuth Quadruple Therapy
Hide Arm/Group Description

pantoprazole 40mg bid 10 days (D1-D10), amoxicillin 1000mg bid 5 days (D1-D5), clarithromycin 500mg bid 5 days (D6-D10), metronidazole 500mg tid 5 days (D6-D10)

Pantoprazole

Amoxicillin

Clarithromycin

Metronidazole

pantoprazole 40mg bid 14 days (D1-D14) , amoxicillin 1000mg bid 14 days (D1-D14), tetracycline 1000mg bid 14 days (D1-D14), bismuth 600mg bid 14 days (D1-D14)

Pantoprazole

Amoxicillin

Tetracycline

Bismuth

All-Cause Mortality
Sequential Therapy Modified Bismuth Quadruple Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Sequential Therapy Modified Bismuth Quadruple Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/195 (0.00%)   0/195 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Sequential Therapy Modified Bismuth Quadruple Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   93/195 (47.69%)   72/195 (36.92%) 
Gastrointestinal disorders     
Bloating   21/195 (10.77%)  11/195 (5.64%) 
Epigastric soreness   15/195 (7.69%)  17/195 (8.72%) 
Taste distortions   24/195 (12.31%)  4/195 (2.05%) 
Nausea   14/195 (7.18%)  6/195 (3.08%) 
Anorexia   2/195 (1.03%)  1/195 (0.51%) 
Vomiting   0/195 (0.00%)  2/195 (1.03%) 
Abdominal pain   4/195 (2.05%)  4/195 (2.05%) 
Dyspepsia   4/195 (2.05%)  4/195 (2.05%) 
Diarrhea   2/195 (1.03%)  12/195 (6.15%) 
Constipation   2/195 (1.03%)  3/195 (1.54%) 
Reflux   1/195 (0.51%)  1/195 (0.51%) 
Stool color change   0/195 (0.00%)  3/195 (1.54%) 
Nervous system disorders     
Headache   1/195 (0.51%)  2/195 (1.03%) 
Dizziness   1/195 (0.51%)  0/195 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash and itching   2/195 (1.03%)  5/195 (2.56%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nayoung Kim, M.D., Ph.D.
Organization: Department of Internal Medicine, Seoul National University Bundang Hospital
Phone: + 82-31-787-7008
EMail: nayoungkim49@empas.com
Layout table for additonal information
Responsible Party: Nayoung Kim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT02159976    
Other Study ID Numbers: B-1403/243-003
First Submitted: June 3, 2014
First Posted: June 10, 2014
Results First Submitted: May 5, 2016
Results First Posted: May 13, 2019
Last Update Posted: May 13, 2019