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Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy 10 Days in the First Line Therapy (THC)

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ClinicalTrials.gov Identifier: NCT01607918
Recruitment Status : Unknown
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 30, 2012
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Study Description
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Brief Summary:
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days

Condition or disease Intervention/treatment Phase
Eradication Rates of the Two Regimens Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole) Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of the Efficacy of Clarithromycin-based Triple Therapy for 14 Days Versus Sequential Therapy for 10 Days in the First Line Therapy for Helicobacter Pylori Infection- A Multicenter Randomized Comparative Trial
Study Start Date : February 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sequential therapy 10 days
Sequential therapy
 Drug: D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
Other Names:
  • Takepron
  • Amoxicillin
  • Klaricid
  • Flagyl
Active Comparator: Triple therapy 14 days
Triple therapy
 Drug: D1-D14: (lansoprazole + clarithromycin + amoxicillin)
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
Other Names:
  • Takepron
  • Klaricid
  • Amoxicillin


Outcome Measures
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Primary Outcome Measures :
  1. Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis [ Time Frame: 6 weeks ]
    C13-UBT will be used to assess the existence of H. pylori


Secondary Outcome Measures :
  1. Incidence of adverse effects [ Time Frame: during eradication therapy ]
    to assess the adverse effects


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients are aged greater than 20 years who have H. pylori infection without prior eradication therapy and are willing to receive the sequential therapy will be eligible for enrollment.
  • Written informed consents will be obtained from all patients prior to enrollment.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria is present:

  • children and teenagers aged less than 20 years,
  • history of gastrectomy,
  • gastric malignancy, including adenocarcinoma and lymphoma,
  • previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole), - contraindication to treatment drugs,
  • pregnant or lactating women,
  • severe concurrent disease
  • Patients who cannot give informed consent by himself or herself.
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): NCT01607918


Contacts
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Contact: Jyh-Ming Liou, MD 886-972651883 dtmed046@pchome.com.tw

Locations
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Taiwan
National Taiwan University Hospital Recruiting
Taipei,, Taiwan, 10002
Contact: Jyh-Ming Liou, MD    886-972651883    dtmed046@pchome.com.tw   
Principal Investigator: Jyh-Ming Liou, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Jyh-Ming Liou, MD National Taiwan University Hospital
Principal Investigator: Ming-Shiang Wu, MD, PhD National Taiwan University Hospital
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: National Taiwan University Hospital, Doctor and Principle Investigator, Department of Gastroenterology
ClinicalTrials.gov Identifier: NCT01607918    
Other Study ID Numbers: 201110019MD
First Posted: May 30, 2012    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013
Keywords provided by National Taiwan University Hospital:
H pylori, eradication
Additional relevant MeSH terms:
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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