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Concomitant, Sequential, and Standard Triple Therapy for H. Pylori Infection

NCT ID: NCT01769365

Last Updated: 2017-11-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-10-31

Brief Summary

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To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

Detailed Description

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The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.

A total of 306 subjects are enrolled into this study.

H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.

Conditions

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Helicobacter Pylori Infection

Keywords

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Helicobacter pylori infection

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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7-day quadruple therapy

1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days,
4. metronidazole 500 mg twice daily for 7 days

Group Type EXPERIMENTAL

7-day quadruple therapy

Intervention Type DRUG

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days

10-day sequential therapy

1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by
2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days.

Group Type EXPERIMENTAL

10-day sequential therapy

Intervention Type DRUG

pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days

7-day standard triple therapy

1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days.

Group Type ACTIVE_COMPARATOR

7-day standard triple therapy

Intervention Type DRUG

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Interventions

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7-day quadruple therapy

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days

Intervention Type DRUG

10-day sequential therapy

pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days

Intervention Type DRUG

7-day standard triple therapy

pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Intervention Type DRUG

Other Intervention Names

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Pantoprazole, amoxicillin, clarithromycin, metronidazole sequential group pantoprazole, clarithromycin, amoxicillin

Eligibility Criteria

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Inclusion Criteria

* Consecutive H. pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis

Exclusion Criteria

* previous H. pylori-eradication therapy
* ingestion of antibiotics, bismuth, or proton pump inhibitors within the prior 4 weeks
* patients with allergic history to the medications used
* patients with previous gastric surgery
* the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia)
* pregnant women
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Ping-I (William) Hsu, M.D.

Chief of Division of Gastroenterology; Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ping-I Hsu, MD

Role: STUDY_CHAIR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

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Taiwan

References

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Hsu PI, Wu DC, Chen WC, Tseng HH, Yu HC, Wang HM, Kao SS, Lai KH, Chen A, Tsay FW. Randomized controlled trial comparing 7-day triple, 10-day sequential, and 7-day concomitant therapies for Helicobacter pylori infection. Antimicrob Agents Chemother. 2014 Oct;58(10):5936-42. doi: 10.1128/AAC.02922-14. Epub 2014 Jul 28.

Reference Type DERIVED
PMID: 25070099 (View on PubMed)

Other Identifiers

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VGHKS99-CT7-10

Identifier Type: -

Identifier Source: org_study_id