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Comparison Efficacy of 14-day Concomitant Therapy:Clarithromycin vs.Levofloxacin in Eradication of H.Pylori

NCT ID: NCT03021590

Last Updated: 2018-12-07

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2022-01-31

Brief Summary

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Comparison Efficacy of 14-day Concomitant therapy between levofloxacin and Clarithromycin on the Eradication of Helicobacter Pylori in Syrian population

Detailed Description

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Conditions

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Helicobacter Pylori Gastrointestinal Tract Infection

Keywords

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Helicobacter pylori Helicobacter Infections Proton Pump Inhibitors sequential therapy Clarithromycin Tinidazole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clarithromycin :Concomitant Therapy

Amoxicillin 1000 mg Tablets, Clarithromycin 500 mg Tablets , Tinidazole 500 mg Tablets and Esomeprazole 20 mg Capsule each every 12 hours for 14 days all by mouth

Group Type EXPERIMENTAL

Clarithromycin 500Mg Oral Tablet

Intervention Type DRUG

Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all

,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth

Levofloxacin :Concomitant Therapy

Levofloxacin 500 mg Tablets Amoxicillin 1000 mg Tablets,Tinidazole 500 mg Tablets and Esomeprazole 20 mg each every 12 hours for 14 days all by mouth

Group Type ACTIVE_COMPARATOR

Levofloxacin 500Mg Oral Tablet

Intervention Type DRUG

Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth

Interventions

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Clarithromycin 500Mg Oral Tablet

Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all

,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth

Intervention Type DRUG

Levofloxacin 500Mg Oral Tablet

Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth

Intervention Type DRUG

Other Intervention Names

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Esomeprazole 40Mg Capsule Amoxicillin 1000Mg Capsule Tinidazole 500Mg Tablet Esomeprazole 40Mg Capsule Amoxicillin 1000Mg Capsule Tinidazole 500Mg Tablet

Eligibility Criteria

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Inclusion Criteria

-Patients are aged greater than 18 years old who have H. pylori infection diagnosed by any of following three methods: I-Positive rapid urease test (CLOtest). II-Histologic evidence of H. pylori by modified Giemsa staining. III-Positive 13C-urea breath test. without prior eradication therapy and are willing to receive therapy.

Exclusion Criteria

* Children and teenagers aged less than 18 years.
* Previous eradication treatment for H. pylori.
* Patients who took any drug, which could influence the study results such as proton pump inhibitor, H2 blocker, mucosal protective agent and antibiotics.
* History of gastrectomy.
* Gastric malignancy, including adenocarcinoma and lymphoma,
* Previous allergic reaction to antibiotics (Amoxicillin, Tinidazole , Levofloxacin) and prompt pump inhibitors (Es-omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease. Liver cirrhosis. Chronic kidney disease.
* Patients who cannot give informed consent by himself or herself.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Damascus Hospital

Damascus, , Syria

Site Status

Countries

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Syria

Other Identifiers

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G5-17

Identifier Type: -

Identifier Source: org_study_id