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

NCT ID: NCT01042184

Last Updated: 2012-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-03-31

Brief Summary

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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

Detailed Description

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Conditions

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H. Pylori Infection

Keywords

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H. pylori infected patients without prior eradication therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sequential therapy for 14 days

Intervention Type DRUG

D1-D7: (lansoprazole 30mg + amoxicillin 1gm) bid D8-D14: (lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg) bi

Group B: Sequential therapy for 10 days

Group Type EXPERIMENTAL

Sequential therapy for 10 days

Intervention Type DRUG

D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid

Group C: Triple therapy for 14 days

Group Type ACTIVE_COMPARATOR

Triple therapy for 14 days

Intervention Type DRUG

D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid

Interventions

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Sequential therapy for 14 days

D1-D7: (lansoprazole 30mg + amoxicillin 1gm) bid D8-D14: (lansoprazole 30mg + clarithromycin 500mg + metronidazole 500mg) bi

Intervention Type DRUG

Sequential therapy for 10 days

D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid

Intervention Type DRUG

Triple therapy for 14 days

D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jyh-Ming Liou, M.D

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type DERIVED
PMID: 23158886 (View on PubMed)

Other Identifiers

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NTUH200909054M

Identifier Type: REGISTRY

Identifier Source: secondary_id

200909054M

Identifier Type: -

Identifier Source: secondary_id

200909054M

Identifier Type: -

Identifier Source: org_study_id