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

January 3, 2010
November 15, 2012
December 2009
February 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01042184 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy of 10-day and 14-day Sequential Therapy Versus Triple Therapy on the Eradication of Helicobacter Pylori
Phase IV Study Comparing the Duration of Sequential Therapy

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
H. Pylori Infection
  • Drug: Sequential therapy for 14 days
    D1-D7: (lansoprazole 30mg + amoxicillin 1gm) bid D8-D14: (lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg) bi
  • Drug: Sequential therapy for 10 days
    D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
  • Drug: Triple therapy for 14 days
    D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
  • 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
    Intervention: Drug: Sequential therapy for 14 days
  • Experimental: Group B: Sequential therapy for 10 days
    Intervention: Drug: Sequential therapy for 10 days
  • Active Comparator: Group C: Triple therapy for 14 days
    Intervention: Drug: Triple therapy for 14 days
Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
900
March 2012
February 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01042184
200909054M, NTUH200909054M, 200909054M
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Jyh-Ming Liou, M.D National Taiwan University Hospital
National Taiwan University Hospital
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP