A Two Week Nitazoxanidebased Quadruple Regimen
Primary Purpose
Dyspepsia
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Nitazoxanide
Levofloxacin
Doxycyclin
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Dyspepsia
Eligibility Criteria
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
Sites / Locations
- Tropical medicine dept.-Tanta university hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quadruple therapy
Arm Description
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
Outcomes
Primary Outcome Measures
Number of patients with eradicated helicobacter
The total number of patients with eradicated helicobacter
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02621359
Brief Title
A Two Week Nitazoxanidebased Quadruple Regimen
Official Title
A Two Week Nitazoxanidebased Quadruple Regimen for Helicobacter Pylori Therapy After Failure of Standard Triple Therapy: A Single Center Experience
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspepsia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quadruple therapy
Arm Type
Experimental
Arm Description
Nitazoxanide (500mg bid), Levofloxacin (500 mg once daily), Omeprazole (40 mg bid) and doxycyclin (100 mg twice daily) were prescribed for 14 days.
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
Alenia, nitclean, parazoxanide
Intervention Description
Nitazoxanide 500 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Tavanic, levoxin, venaxan.
Intervention Description
Levofloxacin 500 mg once daily
Intervention Type
Drug
Intervention Name(s)
Doxycyclin
Other Intervention Name(s)
Vibramycin, Doxymycin
Intervention Description
Doxycyclin 100 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Omepak, Pepzole, Gasec, Risek.
Intervention Description
Omeprazole 40 mg twice daily
Primary Outcome Measure Information:
Title
Number of patients with eradicated helicobacter
Description
The total number of patients with eradicated helicobacter
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sherief Abd-Elsalam, lecturer
Phone
00201095159522
Email
sherif_tropical@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, lecturer
Organizational Affiliation
Tropical medicine-Tanta university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical medicine dept.-Tanta university hospital
City
Tanta
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sherief Abd-Elsalam, lecturer
Phone
00201095159522
Email
Sherif_tropical@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
A Two Week Nitazoxanidebased Quadruple Regimen
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