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LOAD VS Levofloxacine Concomitant

NCT ID: NCT04626193

Last Updated: 2020-11-12

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2024-05-30

Brief Summary

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Comparison Efficacy of two weeks Therapy with Doxycycline,levofloxacine,Tinadizole Versus Levofloxacine,Tinadizole,Amocillin on Eradication of Helicobacter Pylori in Syrian population.

Detailed Description

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Conditions

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Helicobacter Pylori Infection

Keywords

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Doxycycline LOAD regimen Helicobacter Pylori levofloxacine tinadizole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Doxycyclien

Measure eradication rate of Helicobacter pylori infection with Doxycycline,Levofloxacien,tinadizole

Group Type EXPERIMENTAL

Doxycycline

Intervention Type DRUG

Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid

Levofloxacine

Measure eradication rate of Helicobacter pylori infection with Livofloxacine and tinadizole,amoxicilline

Group Type ACTIVE_COMPARATOR

Levofloxacin 500mg

Intervention Type DRUG

Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Interventions

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Doxycycline

Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid

Intervention Type DRUG

Levofloxacin 500mg

Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid

Intervention Type DRUG

Other Intervention Names

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Tinadizole Esomeprazole levofloxacine Amoxicilline Esomeprazol Tinadizole

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:
* Positive rapid urease test (CLOtest).
* Histologic evidence of H. pylori by modified Giemsa staining.
* 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, Tinadizole,
* Doxycycline,Bismuth subsalicylate,) and prompt pump inhibitors (Es- omeprazole).
* Contraindication to treatment drugs.
* Pregnant or lactating women.
* Severe concurrent disease.
* Liver cirrhosis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 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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Marouf Alhalabi

head of digestive diseases department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marouf M Alhalabi, MD

Role: PRINCIPAL_INVESTIGATOR

general assambly of damascus hospital

Locations

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General Assembly of Damascus Hospital

Damascus, , Syria

Site Status RECRUITING

Countries

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Syria

Central Contacts

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Marouf MH Alhalabi, MD

Role: CONTACT

Phone: +963952781278

Email: [email protected]

Facility Contacts

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Marouf MI Alhalabi, MD

Role: primary

Other Identifiers

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G-10-20

Identifier Type: -

Identifier Source: org_study_id