Efficacy of 10-day and 14-day Sequential Therapy Versus Triple Therapy on the Eradication of Helicobacter Pylori

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01042184
First received: January 3, 2010
Last updated: November 15, 2012
Last verified: June 2012
  Purpose

Background: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection could reduce the occurence or recurrence of these diseases. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. It was estimated that 15-20% of patients would fail from first line standard eradication therapy and need second line rescue therapy. About 15-30% of patient would fail from second line therapy and need to be rescued with third line therapy. In recent years, the concept of sequential therapy has been advocated in the treatment of H. pylori infection. The regimen includes a PPI plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The eradication rate in the first line treatment of sequential therapy had been reported to be as high as 90%. More importantly, it has been demonstrated that the eradication rate among patients with clarithromycin-resistant strains could be as high as 89%. However, tinidazole is not available in many countries. Whether metronidazole would be an effective alternative to tinidazole in the sequential therapy remains unknown. Besides, whether extending the duration of sequential therapy from 10-day to 14-day would result in higher eradication rate also deserves further investigation. Furthermore, data on the efficacy of rescue regimens for patients who failed from first line sequential therapy are also lacking. The impact of clarithromycin, metronidazole resistance and CYP2C19 polymorphism on the sequential therapy containing metronidazole (rather than tinidazole) also has not been reported.

Aims: Therefore, we aim to assess

  1. whether the substitution of metronidazole for tinidazole in the sequential therapy is also more effective than clarithromycin-based triple therapy
  2. whether extending the duration of sequential therapy from 10-day to 14-day would achieve higher eradication rate
  3. whether levofloxacin-based sequential therapy for 14-days is effective as second line rescue regimen for those who failed from first line sequential therapy
  4. the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy

Condition Intervention Phase
H. Pylori Infection
Drug: Sequential therapy for 14 days
Drug: Sequential therapy for 10 days
Drug: Triple therapy for 14 days
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV Study Comparing the Duration of Sequential Therapy

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 after eradication therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of sequential therapy [ Time Frame: 6 weeks after eradication therapy ] [ Designated as safety issue: No ]

Enrollment: 900
Study Start Date: December 2009
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Group A: Sequential therapy for 14 days D1-D7: (lansoprazole 30mg + amoxicillin 1gm) bid D8-D14: (lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg) bid
Drug: Sequential therapy for 14 days
D1-D7: (lansoprazole 30mg + amoxicillin 1gm) bid D8-D14: (lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg) bi
Experimental: Group B: Sequential therapy for 10 days Drug: Sequential therapy for 10 days
D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
Active Comparator: Group C: Triple therapy for 14 days Drug: Triple therapy for 14 days
D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

1. 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.

Exclusion Criteria:

  1. children and teenagers aged less than 20 years,
  2. history of gastrectomy,
  3. gastric malignancy, including adenocarcinoma and lymphoma,
  4. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, levofloxacin, metronidazole) and prompt pump inhibitors (lansoprazole),
  5. contraindication to treatment drugs,
  6. pregnant or lactating women,
  7. severe concurrent disease,
  8. Patients who cannot give informed consent by himself or herself.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042184

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Jyh-Ming Liou, M.D National Taiwan University Hospital
  More Information

No publications provided by National Taiwan University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01042184     History of Changes
Other Study ID Numbers: 200909054M, NTUH200909054M, 200909054M
Study First Received: January 3, 2010
Last Updated: November 15, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
H. pylori infected patients without prior eradication therapy

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Clarithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014