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Modified Non-clarithromycin Triple Therapy in Eradicating Helicobacter Pylori

NCT ID: NCT02776371

Last Updated: 2018-12-24

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

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-02-28

Brief Summary

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Helicobacter pylori (H. pylori) infects more than 50% of the population in the world(1), especially 47-66% in China.

Detailed Description

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Conditions

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Helicobacter Pylori Eradication Rate

Keywords

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Helicobacter pylori Sequential therapy Modified non-clarithromycin triple 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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Modified non-clarithromycin triple therapy

H.pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Group Type EXPERIMENTAL

Modified non-clarithromycin triple therapy

Intervention Type DRUG

H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Sequential therapy

H.pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Group Type ACTIVE_COMPARATOR

Sequential therapy

Intervention Type DRUG

H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Interventions

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Modified non-clarithromycin triple therapy

H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.

Intervention Type DRUG

Sequential therapy

H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who were intend to undergo upper endoscopy for any purpose and volunteered to written inform consent.

Exclusion Criteria

* negative in rapid urease test (RUT)
* previous standard eradication therapy for H. pylori;
* history of esophagectomy or gastrectomy;
* gastrointestinal malignancy;
* contraindications or allergic to study drugs;
* user of taking medicine that may affect the result of the study within 4 weeks (e.g., proton-pump inhibitors, H2-receptor antagonists, bismuth or antibiotics etc.);
* cardiopulmonary, hepatic or renal insufficiency, and/or severe current diseases or malignancy;
* pregnant or lactating women;
* participants of other trial within the past 3 months;
* unwilling or unable to participate in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Yanqing Li

Vice president of Qilu Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Li Yanqing, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Countries

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China

Other Identifiers

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2016SDU-QILU-05

Identifier Type: -

Identifier Source: org_study_id