A Two Week Nitazoxanidebased Quadruple Regimen

NCT ID: NCT02621359

Last Updated: 2018-01-03

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

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2022-12-31

Brief Summary

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Helicobacter pylori (H. pylori) infection is a global health problem as it is associated with peptic ulcers, chronic gastritis, duodenitis, and stomach cancer.

Therefore, the eradication of the pathogen is of critical importance to reduce H. pylori-related complications .

However, due to increasing antibiotic resistance, eradication of Helicobacter pylori has become more challenging. With a great decline in the eradication rate of standard triple therapy for Helicobacter pylori to below 70% in many countries.

Treatment with triple therapy, which is the most frequently recommended, fails to eradicate H. pylori in approximately 20% of cases .

Detailed Description

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Designing a new rescue regimen that achieves greater than 85% eradication rate is an important target of current research.

Unfortunately, the most frequently used "rescue" or "salvage" therapy is bismuth quadruple therapy consisting of a proton pump inhibitor (PPI), tetracycline, metronidazole, and bismuth \[11\]. This rescue therapy is inexpensive, and relatively effective with average eradication rate of 70% when used as second-line therapy. However, disadvantages of bismuth based quadruple therapy include the large daily number of pills (sometimes exceeding 18 pills), increased dosing frequency (four times daily), and frequent side effects.

Conditions

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Dyspepsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quadruple therapy

Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

Nitazoxanide 500 mg twice daily

Levofloxacin

Intervention Type DRUG

Levofloxacin 500 mg once daily

Doxycyclin

Intervention Type DRUG

Doxycyclin 100 mg twice daily

Omeprazole

Intervention Type DRUG

Omeprazole 40 mg twice daily

Interventions

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Nitazoxanide

Nitazoxanide 500 mg twice daily

Intervention Type DRUG

Levofloxacin

Levofloxacin 500 mg once daily

Intervention Type DRUG

Doxycyclin

Doxycyclin 100 mg twice daily

Intervention Type DRUG

Omeprazole

Omeprazole 40 mg twice daily

Intervention Type DRUG

Other Intervention Names

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Alenia, nitclean, parazoxanide Tavanic, levoxin, venaxan. Vibramycin, Doxymycin Omepak, Pepzole, Gasec, Risek.

Eligibility Criteria

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Inclusion Criteria

* Patients with helicobacter infection.
* in whom the standard triple therapy (clarithromycin-based triple therapy) failed

Exclusion Criteria

* Patients under 18 or over 65 years of age.
* Those with co-existing serious illnesses such as liver cirrhosis, uremia and gastrointestinal malignancies
* pregnancy/lactation
* having contraindication or allergy to any of the study drugs
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Sherief Abd-Elsalam

Hepatology and Gastroenterology Dept., Tanta university, M.D., Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sherief Abd-Elsalam, lecturer

Role: PRINCIPAL_INVESTIGATOR

Tropical medicine-Tanta university hospital

Locations

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Tropical medicine dept.-Tanta university hospital

Tanta, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sherief Abd-Elsalam, lecturer

Role: CONTACT

00201095159522

Facility Contacts

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Sherief Abd-Elsalam, lecturer

Role: primary

00201095159522

Other Identifiers

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Quadruple therapy

Identifier Type: -

Identifier Source: org_study_id

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