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Comparison of 7-day and 14-day Bismuth Based Quadruple Therapy for Secondary Helicobacter Pylori Eradication

NCT ID: NCT00841854

Last Updated: 2016-12-06

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

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2010-11-30

Brief Summary

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At present, triple therapy are recommended by various guidelines for the treatment of Helicobacter pylori (H. pylori) infection. Recent studies have shown worldwide high treatment failure rates with one week first line clarithromycin based triple therapy necessitating salvage strategy to eradicate H. pylori in primary treatment failure. However, the exact duration of bismuth based second line treatment is not determined. Therefore, the investigators performed this study to evaluate the eradication rate of 1 or 2-week quadruple regimen as a second-line therapy.

Detailed Description

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Conditions

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Helicobacter Infection

Keywords

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Helicobacter pylori Bismuth Salvage treatment Metronidazole

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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PBMT7

pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 7 days

Group Type ACTIVE_COMPARATOR

pantoprazole

Intervention Type DRUG

pantoprazole 40mg bid

bismuth

Intervention Type DRUG

bismuth 300mg qid

metronidazole

Intervention Type DRUG

metronidazole 500mg tid

tetracycline

Intervention Type DRUG

tetracycline 500mg qid

PBMT14

pantoprazole 40mg bid, bismuth 300mg qid, metronidazole 500mg tid,tetracycline 500mg qid for 14 days

Group Type ACTIVE_COMPARATOR

pantoprazole

Intervention Type DRUG

pantoprazole 40mg bid

bismuth

Intervention Type DRUG

bismuth 300mg qid

metronidazole

Intervention Type DRUG

metronidazole 500mg tid

tetracycline

Intervention Type DRUG

tetracycline 500mg qid

Interventions

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pantoprazole

pantoprazole 40mg bid

Intervention Type DRUG

bismuth

bismuth 300mg qid

Intervention Type DRUG

metronidazole

metronidazole 500mg tid

Intervention Type DRUG

tetracycline

tetracycline 500mg qid

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* H. pylori infection
* Aged between 18-80 years
* Are willing to received eradication therapy for H. pylori

Exclusion Criteria

* Children and teenagers aged less than 18 years or over 80 years
* Previous eradication therapy for H. pylori
* History of gastrectomy
* Previous allergic reaction to antibiotics
* Use of prompt pump inhibitors and antibiotics in the recent 4 weeks
* Active upper GI bleeding in the recent 1 week
* Contraindication to treatment drugs
* Pregnant or lactating women
* Severe concurrent disease or malignancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inje University

OTHER

Sponsor Role collaborator

Pacific Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Hwoon-Yong Jung

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hwoon-Yong Jung, M.D

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Chung JW, Lee JH, Jung HY, Yun SC, Oh TH, Choi KD, Song HJ, Lee GH, Kim JH. Second-line Helicobacter pylori eradication: a randomized comparison of 1-week or 2-week bismuth-containing quadruple therapy. Helicobacter. 2011 Aug;16(4):289-94. doi: 10.1111/j.1523-5378.2011.00844.x.

Reference Type DERIVED
PMID: 21762268 (View on PubMed)

Other Identifiers

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2008-0088

Identifier Type: -

Identifier Source: org_study_id