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

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. 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
Information provided by (Responsible Party):
National Taiwan University Hospital

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

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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

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

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

Information from the National Library of Medicine

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

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.

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 identifier (NCT number): NCT01607918

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Contact: Jyh-Ming Liou, MD 886-972651883

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National Taiwan University Hospital Recruiting
Taipei,, Taiwan, 10002
Contact: Jyh-Ming Liou, MD    886-972651883   
Principal Investigator: Jyh-Ming Liou, MD         
Sponsors and Collaborators
National Taiwan University Hospital
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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
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Taiwan University Hospital, Doctor and Principle Investigator, Department of Gastroenterology 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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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