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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01607918
First received: February 16, 2012
Last updated: October 27, 2013
Last verified: October 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607918

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

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

Publications:
Responsible Party: National Taiwan University Hospital, Doctor and Principle Investigator, Department of Gastroenterology
ClinicalTrials.gov 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:
Amoxicillin
Clarithromycin
Lansoprazole
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Synthesis Inhibitors

ClinicalTrials.gov processed this record on July 20, 2014