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Trial record 89 of 150 for:    tetracycline

Tailored Therapy for Clarithromycin-Resistant H. Pylori

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ClinicalTrials.gov Identifier: NCT03431688
Recruitment Status : Recruiting
First Posted : February 13, 2018
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Shin, Woon Geon, Kangdong Sacred Heart Hospital

Brief Summary:
Clarithromycin-resistant H. pylori is the main cause of H. pylori eradication failure. Tailored therapy on the basis of detection of a clarithromycin resistance mutation by PCR has been studied recently, however, there have been few studies comparing treatment regimen in patient with clarithromycin-resistant H. pylori. We used sequencing-based clarithromycin resistance mutation and aimed to compare PAM (proton pump inhibitor, amoxicilline, metronidazole) regimen and PBMT (proton pump inhibitor, bismuth, metronidazole, tetracyclin) regimen in patient with clarithromycin-resistant H. pylori.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: PAM Drug: PBMT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy Comparison of Metronidazole-based Triple and Bismuth-based Quadruple Therapy for Clarithromycin Resistant-Helicobacter Pylori Infection: Randomized Controlled Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PAM
treatment with PPI, metonidazole, amoxicillin
Drug: PAM
treatment with PPI, metonidazole, amoxicillin

Active Comparator: PBMT
treatment with PPI, metonidazole, bismuth, tetracyclin
Drug: PBMT
treatment with PPI, metonidazole, bismuth, tetracyclin




Primary Outcome Measures :
  1. H. pylori eradication rate [ Time Frame: 14 days ]
    H. pylori eradication rate



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • peptic ulcer disease
  • H. pylori gastritis
  • low grade MALT lymphoma

Exclusion Criteria:

  • history of gastric cancer surgery
  • severe comorbidity (ESRD, LC)
  • hypersensitivity to drug
  • pregnancy

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): NCT03431688


Contacts
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Contact: Woon Geon Shin 82-2-2225-2814 sgun9139@gmail.com

Locations
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Korea, Republic of
Kangdong Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 134-701
Contact: Woon Geon Shin, MD    82-2-2225-2814    sgun9139@gmail.com   
Principal Investigator: Woon Geon Shin, MD         
Sponsors and Collaborators
Kangdong Sacred Heart Hospital
Investigators
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Principal Investigator: Woon Geon Shin Kangdong Sacred Heart Hospital

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Responsible Party: Shin, Woon Geon, Woon Geon Shin, Kangdong Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT03431688     History of Changes
Other Study ID Numbers: KangdongSHH
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Clarithromycin
Bismuth
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antacids
Gastrointestinal Agents