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Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy

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ClinicalTrials.gov Identifier: NCT02108184
Recruitment Status : Unknown
Verified February 2016 by Sung min, Park, Incheon St.Mary's Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2014
Last Update Posted : February 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sung min, Park, Incheon St.Mary's Hospital

Study Description
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Brief Summary:

Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea.

single center, randomized trial

  1. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 10 days
  2. (pantoprazole 40 mg + amoxicillin 1.0g + clarithromycin 500 mg + metronidazole 500 mg) twice for 14 days
  3. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 5 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 5 days
  4. (pantoprazole 40 mg + amoxicillin 1.0g) twice for 7 days and subsequent pantoprazole 40mg + clarithromycin 500 mg + metronidazole 500 mg) twice for 7 days

1st endpoint : Helicobacter pylori eradication rates (intention to treatment, per-protocol) 2nd endpoint : adverse event(nausea, vomiting, dizziness, bitter sense) drug compliance


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Sequential therapy 10 days Drug: Sequential therapy 14 days Drug: Concomitant therapy 10 days Drug: Concomitant therapy 14 days Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy of Treatment of Helicobacter Pylori Infection in Korea
Study Start Date : February 2014
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequential therapy 10 days
1.(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 5 days
 Drug: Sequential therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg ) bid for the next 5 days : Sequential therapy 1
Active Comparator: Sequential therapy 14 days
(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days
 Drug: Sequential therapy 14 days
(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days : Sequential therpay 2
Active Comparator: Concomitant therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 10 days
 Drug: Concomitant therapy 10 days
(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1
Active Comparator: Concomitant therapy 14 days
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days
 Drug: Concomitant therapy 14 days
(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of the eradications rates of sequential therapy versus concomitant therapy of treatment of Helicobacter pylori infection in Korea. [ Time Frame: required average 10 weeks to assess Helicobacter pylori eradication rate from 1st visit ]
    To assess Helicobacter pylori eradication rates


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 20~80 patients
  • agreement of informed consent
  • H.pylori positive (biopsy, CLO)
  • Peptic ulcer disease, mucosa associated lymphoid tissue lymphoma, Post endoscopic submucosal dissection status due to early gastric cancer

Exclusion Criteria:

  • H.pylori eradication history
  • severe hepatic, renal, cardiac failure
  • pregnancy, participant of other study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108184


Contacts
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Contact: Sung min Park 082-032-280-5052 danson2000@hanmail.net

Locations
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Korea, Republic of
Incheon St.Mary hospital Recruiting
Incheon, Bupyung, Korea, Republic of, KSXX0009
Contact: Sungmin Park         
Sponsors and Collaborators
Incheon St.Mary's Hospital
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Sung min, Park, fellow, Incheon St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT02108184    
Other Study ID Numbers: PSungmin
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: February 25, 2016
Last Verified: February 2016
Keywords provided by Sung min, Park, Incheon St.Mary's Hospital:
helicobacter eradication rates
Additional relevant MeSH terms:
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Infections
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses