A Two Week Nitazoxanidebased Quadruple Regimen

NCT02621359 | Unknown Phase 3 DMC

• 1 other identifier: Quadruple therapy
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Dyspepsia

Outcome Measures

Primary Outcomes (1)

• Number of patients with eradicated helicobacter

  The total number of patients with eradicated helicobacter

  1 year

Study Arms (1)

Quadruple therapy

EXPERIMENTAL

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

Drug: Nitazoxanide; Drug: Levofloxacin; Drug: Doxycyclin; Drug: Omeprazole

Interventions

Nitazoxanide DRUG

Nitazoxanide 500 mg twice daily

Also known as: Alenia, nitclean, parazoxanide

Quadruple therapy

Levofloxacin DRUG

Levofloxacin 500 mg once daily

Also known as: Tavanic, levoxin, venaxan.

Quadruple therapy

Doxycyclin DRUG

Doxycyclin 100 mg twice daily

Also known as: Vibramycin, Doxymycin

Quadruple therapy

Omeprazole DRUG

Omeprazole 40 mg twice daily

Also known as: Omepak, Pepzole, Gasec, Risek.

Quadruple therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tropical medicine dept.-Tanta university hospital

Tanta, Egypt

RECRUITING

MeSH Terms

Conditions

Dyspepsia

Interventions

nitazoxanide; Levofloxacin; Ofloxacin; Doxycycline; Omeprazole

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Sherief Abd-Elsalam, lecturer

  Tropical medicine-Tanta university hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sherief Abd-Elsalam, lecturer

CONTACT

00201095159522; sherif_tropical@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hepatology and Gastroenterology Dept., Tanta university, M.D., Principle investigator

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 3, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 3, 2018

Record last verified: 2017-12

Locations

EG (1)