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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2013 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
National Taiwan University Hospital Identifier:
First received: February 16, 2012
Last updated: October 27, 2013
Last verified: October 2013
The investigators aimed to compare the eradication rates of sequential therapy for 10 days versus triple therapy for 14 days

Condition Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Eradication rate according to Intention to treat (ITT) and per-protocol (PP) analysis [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    C13-UBT will be used to assess the existence of H. pylori

Secondary Outcome Measures:
  • Incidence of adverse effects [ Time Frame: during eradication therapy ] [ Designated as safety issue: Yes ]
    to assess the adverse effects

Estimated Enrollment: 1300
Study Start Date: February 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01607918

Contact: Jyh-Ming Liou, MD 886-972651883

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
Principal Investigator: Jyh-Ming Liou, MD National Taiwan University Hospital
Principal Investigator: Ming-Shiang Wu, MD, PhD National Taiwan University Hospital
  More Information

Responsible Party: National Taiwan University Hospital, Doctor and Principle Investigator, Department of Gastroenterology Identifier: NCT01607918     History of Changes
Other Study ID Numbers: 201110019MD
Study First Received: February 16, 2012
Last Updated: October 27, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by National Taiwan University Hospital:
H pylori, eradication

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Ulcer Agents
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Synthesis Inhibitors
Proton Pump Inhibitors
Radiation-Sensitizing Agents
Therapeutic Uses processed this record on November 25, 2015