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Effectiveness of Clarithromycin Based and Levofloxacin Based Quadruple Therapy in Combination with Atorvastatin for Helicobacter Pylori Eradication

Protocol summary

Study aim
Comparison of clarithromycin based and levofloxacin based quadruple therapy in combination with atorvastatin for Helicobacter pylori eradication
Design
Randomized clinical trial, with two arm parallel group of 200 patients, will be enrolled between October 2020 and March 2021.
Settings and conduct
In this research, 200 eligible patients need to Helicobacter pylori eradication referring to Qom hospital will be selected. Then, patients by block randomization will be divided randomly into two interventions groups. The first intervention group will receive clarithromycin based quadruple therapy and second intervention group will receive levofloxacin based quadruple therapy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: aged between 18-75, need to Helicobacter pylori eradicate
Intervention groups
Intervention group: Pentoprazole 40 tablet, Octover company, orally, twice a day + Atorvastatin 40 tablet, orally, once a day + Bismuth 500 tablet, orally, four times a day + Amoxicillin 1 g capsule , orally, twice a day + Clarithromycin 500 tablet (Ferromilide, Octover company), orally, twice a day, for 14 days and control group: Pentoprazole 40 tablet, Octover company, orally, twice a day + Atorvastatin 40 tablet, orally, once a day + Bismuth 500 tablet, orally, four times a day + Amoxicillin 1 g capsule , orally, twice a day + Levofloxacin 500 tablet, Abidi company, orally, once daily for 14 days
Main outcome variables
Helicobacter pylori eradication

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200929048884N1
Registration date: 2020-10-05, 1399/07/14
Registration timing: prospective

Last update: 2020-10-05, 1399/07/14
Update count: 0
Registration date
2020-10-05, 1399/07/14
Registrant information
Name
Javad Khodadadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3261 7638
Email address
jkhodadadi@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-11, 1399/07/20
Expected recruitment end date
2021-03-10, 1399/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Clarithromycin Based and Levofloxacin Based Quadruple Therapy in Combination with Atorvastatin for Helicobacter Pylori Eradication
Public title
Clarithromycin Based and Levofloxacin Based Quadruple Therapy in Helicobacter Pylori Eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Aged between 18-75 Need to Helicobacter pylori eradicate
Exclusion criteria:
Receive previous treatment to eradicate Helicobacter pylori History of allergies to the drugs used in the study
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be assigned to 2 groups of interventions by block randomization. For this purpose blocks of size 4 will be used. 50 blocks will include. To hide the random allocation, the numbered dark envelopes will be used, in which the group name is specified in the random sequence generated. Then, according to the order of entering samples, for the first patient the envelope number one is opened and the group will be identified until the end
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Qom University of Medical Sciences
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Approval date
2020-04-28, 1399/02/09
Ethics committee reference number
IR.MUQ.REC.1399.082

Health conditions studied

1

Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B96.81
ICD-10 code description
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Helicobacter pylori eradication
Timepoint
One month after the end of treatment
Method of measurement
Stool antigen test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pentoprazole 40 tablet, Octover company, orally, twice a day + Atorvastatin 40 tablet, orally, once a day + Bismuth 500 tablet, orally, four times a day + Amoxicillin 1 g capsule , orally, twice a day + Clarithromycin 500 tablet (Ferromilide, Octover company), orally, twice a day, for 14 days
Category
Treatment - Drugs

2

Description
Control group: Pentoprazole 40 tablet, Octover company, orally, twice a day + Atorvastatin 40 tablet, orally, once a day + Bismuth 500 tablet, orally, four times a day + Amoxicillin 1 g capsule , orally, twice a day + Levofloxacin 500 tablet, Abidi company, orally, once daily for 14 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hosbital
Full name of responsible person
Ahmad Hormati
Street address
Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Square.
City
Qom
Province
Ghoum
Postal code
3719964797
Phone
+98 25 3612 2824
Email
hormatia@muq.ac.ir

2

Recruitment center
Name of recruitment center
Kamkar Hospital
Full name of responsible person
Javad Khodadadi
Street address
Kamkar Hospital, 19 Day Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3770 6470
Email
jkhodadadi@muq.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Ehsan Sharifipour
Street address
No. 83, 4th alley, 1.1 alley, Safashahr Blvd
City
Qom
Province
Ghoum
Postal code
3716987366
Phone
+98 25 3285 2720
Email
research@muq.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Javad Khodadadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Kamkar Hospital, 19 Dey Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3261 7638
Fax
Email
jkhodadadi@muq.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Javad Khodadadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Kamkar Hospital, 19 Dey Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3261 7638
Fax
Email
jkhodadadi@muq.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Javad Khodadadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Kamkar Hospital, 19 Dey Street, Qom
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3261 7638
Fax
Email
jkhodadadi@muq.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data are specific to this study
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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