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Helicobacter Pylori Eradication Study

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ClinicalTrials.gov Identifier: NCT03130452
Recruitment Status : Unknown
Verified April 2017 by Kim Ji Hyun, Inje University.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Kim Ji Hyun, Inje University

Brief Summary:
The purpose of this study was to evaluate the efficacy and compliance of tailored therapy which using the polymerase chain reaction for point mutation of clarithromycin, compared to concomitant therapy, in patients without history of H. pylori eradication.

Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Lansoprazole 30mg Drug: Amoxicillin 1.0g Tab Drug: Clarithromycin 500mg Drug: Metronidazole 500 mg Phase 4

Detailed Description:

Purpose of Study>

  1. To evaluate the efficacy of tailored therapy compared to concomitant therapy.
  2. Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin.
  3. To evaluate the compliance of tailored therapy compared to concomitant.
  4. To analysis of factors which influence to the eradication rate.

Patients>

; Target disease

  • peptic ulcers(gastric ulcer, duodenal ulcer),
  • gastric MALToma,
  • Endoscopic therapy state of early gastric cancer or gastric adenoma,
  • Patients who require H. pylori testing by clinical judgment, such as chronic gastritis.

Method>

Patients with H. pylori infection who have been screened for a 23S ribosomal RNA point mutation (A2142G, A2143G point mutation) and randomized to a concomitant treatment group and a tailored treatment group. In concomitant treatment group, lansoprazole 30 mg, amoxicillin 1.0 g, metronidazole 500 mg and clarithromycin 500 mg were administered twice a day for 2 weeks, regardless of 23S ribosomal RNA point mutation. In tailored treatment group, In the case of 23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks. In tailored treatment group, In point mutation positive cases, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks. For each treatment group, at least 4 weeks after completion of drug administration, confirm the sterilization and confirm the compliance and adverse effects of the drug.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Helicobacter Pylori Eradication Rates of Concomitant Therapy and Tailored Therapy Based on 23S Ribosomal RNA Point Mutations Associated With Clarithromycin Resistance: A Multicenter Prospective Randomized Study
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : February 28, 2018
Estimated Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: concomitant group
lansoprazole 30 mg tablet, amoxicillin 1.0 g tablet, metronidazole 500 mg tablet and clarithromycin 500 mg tablet by mouth every 12 hours for 2 weeks, regardless of 23S ribosomal RNA point mutation.
Drug: Lansoprazole 30mg
lansoprazole 30 mg tablet
Other Name: langton

Drug: Amoxicillin 1.0g Tab
Amoxicillin 1.0g tablet
Other Name: amoxiclav

Drug: Clarithromycin 500mg
Clarithromycin 500mg tablet
Other Name: clavacin

Drug: Metronidazole 500 mg
Metronidazole 500 mg tablet
Other Name: lysinyl

Experimental: tailored treatment group I
23S ribosomal RNA point mutation negative, lansoprazole 30 mg, amoxicillin 1.0 g, and clarithromycin 500 mg were administered twice a day for 2 weeks.
Drug: Lansoprazole 30mg
lansoprazole 30 mg tablet
Other Name: langton

Drug: Amoxicillin 1.0g Tab
Amoxicillin 1.0g tablet
Other Name: amoxiclav

Drug: Clarithromycin 500mg
Clarithromycin 500mg tablet
Other Name: clavacin

Experimental: tailored treatment group II
23S ribosomal RNA point mutation positive, lansoprazole 30 mg, amoxicillin 1.0 g and metronidazole 500 mg For 2 weeks.
Drug: Lansoprazole 30mg
lansoprazole 30 mg tablet
Other Name: langton

Drug: Clarithromycin 500mg
Clarithromycin 500mg tablet
Other Name: clavacin

Drug: Metronidazole 500 mg
Metronidazole 500 mg tablet
Other Name: lysinyl




Primary Outcome Measures :
  1. Comparison of success rate of H. pylori eradication between tailored therapy and concomitant therapy. [ Time Frame: At 4 weeks after the completion of drug administration, the urea breath test is performed to check for eradication, Before the urea breath test, the proton pump inhibitor or H2 blocker should be discontinued for 2 weeks. ]
    Comparison of percentage of people who succeeded in H. pylori eradication among all participants in each treatment group (tailored therapy vs concomitant therapy)


Secondary Outcome Measures :
  1. Difference in eradication rate according to the frequency of 23S ribosomal RNA point mutation in clarithromycin [ Time Frame: Before the treatment, 23S ribosomal RNA point mutation is confirmed and at least 4 weeks after the end of treatment, urea breath test is performed to check whether or not eradication is completed. ]
    Identify the effect of 23S ribosomal RNA point mutation on the eradication rate regardless of the administration drug.


Other Outcome Measures:
  1. Number of remaining medicines of tailored therapy compared to concomitant therapy [ Time Frame: At 4 weeks after the completion of drug administration, when the patient visited for the urea breath test, check the number of remaining medicines. ]
    After taking the treatment drug, take out all remaining medicine in the outpatient clinic room, check the number of remaining medicines, and judge compliance.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • H. pylori infection diagnosed patient, between 18 years old and 80 years old
  • No history of H. pylori eradication therapy
  • No antibiotic use for more than 3 days within 1 month of treatment

Exclusion Criteria:

  • History of taking antibiotics for more than 3 days in the last 1 month
  • History of subtotal or partial gastrectomy
  • Patients with other systemic disorders such as severe liver function, kidney function, cardiopulmonary function abnormality
  • Pregnant and lactating women
  • Disagree with the survey or do not respond to the questionnaire
  • Contraindications for each medications

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): NCT03130452


Locations
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Korea, Republic of
Inje University Busan Paik hosipital
Busan, Korea, Republic of
Sponsors and Collaborators
Inje University
Investigators
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Principal Investigator: Ji Hyun Kim Inje University Busan Paik hosipital

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Responsible Party: Kim Ji Hyun, Clinical Professor, Inje University
ClinicalTrials.gov Identifier: NCT03130452     History of Changes
Other Study ID Numbers: 2016-09-0025
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual patient data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Amoxicillin
Metronidazole
Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors