Comparison of effectiveness of moxifloxacin, amoxicillin and pantoprazole regimen with clarithromycin-based four-drug regimen for eradicating Helicobacter pylori infection
Comparison of effectiveness of moxifloxacin, amoxicillin and pantoprazole regimen with clarithromycin-based four-drug regimen for eradicating Helicobacter pylori infection
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 246 patients. Randomization will be done in such a way that people are divided into two groups based on the first four-way random permutation completely randomly (by a person who was not involved in the study process).
Settings and conduct
The present study will be conducted as a double-blind randomized clinical trial on patients with confirmed Helicobacter infection referred to the clinic and endoscopy department of Imam Khomeini Hospital in Ahvaz in 1403. He receives the antibiotic regimen and his details are recorded in the questionnaire for further follow-up.
Participants/Inclusion and exclusion criteria
All people willing to participate in the study, over 18 years old, with a positive test for Helicobacter pylori and without a history of treatment for this disease will be included in the study, and people with a history of stomach surgery and treatment, pregnant and lactating people will not be included.
Intervention groups
In the intervention group, the regimen is based on moxifloxacin and in the control group, the standard four-drug regimen is based on clarithromycin.
Main outcome variables
Age; gender; therapy groups; drug side effects ; acceptance of medication; Eradication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240128060832N1
Registration date:2024-02-24, 1402/12/05
Registration timing:prospective
Last update:2024-02-24, 1402/12/05
Update count:0
Registration date
2024-02-24, 1402/12/05
Registrant information
Name
Amir Hooshang Bavarsad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3333 4663
Email address
bavarsad-ah@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-20, 1403/01/01
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of moxifloxacin, amoxicillin and pantoprazole regimen with clarithromycin-based four-drug regimen for eradicating Helicobacter pylori infection
Public title
Investigating the effect of moxifloxacin in Helicobacter infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age above 18 years
All patients with PUD, peptic ulcer, non-ulcer dyspepsia and intestinal metaplasia (based on pathology samples) underwent endoscopic evaluation and H. pylori positive confirmation by Rapid urease test (RUT).
No previous treatment of H. pylori infection
Patient consent to participate in the study
Exclusion criteria:
Unwillingness to participate in the study
Taking antibiotics or non-steroidal anti-inflammatory drugs (NSAID) in the last 4 weeks
Allergy to any of the study drugs
A history of gastric surgery or the presence of a serious concurrent disease such as cancer
Pregnant or lactating women
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
246
Randomization (investigator's opinion)
Randomized
Randomization description
People will be divided into two groups based on the first quadruple random permutation completely randomly (by a person who had no involvement in the study process). Also, matching will be done based on age and gender.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is done in such a way that the person who performs the randomization and allocation of people to groups will not have any information about the condition of the patients. The patient and the person who examines the results will not have any information about which group the people are placed in, and the study is conducted in a double-blind manner.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Jundi Shapur Ahvaz University of Medical Sciences
Street address
Vice President of Research and Technology Development, Esfand St., Jundishapur University of Medical Sciences, Golestan Blvd.,
City
Ahwaz
Province
Khouzestan
Postal code
6135715794
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.AJUMS.REC.1402.419
Health conditions studied
1
Description of health condition studied
Helicobacter pylori infection
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified to other chapters
Primary outcomes
1
Description
Determination of positive or negative Helicobacter infection by fecal antigen test
Timepoint
Helicobacter test before and two weeks after treatment
Method of measurement
Helicobacter pylori fecal antigen
Secondary outcomes
1
Description
Drug side effects
Timepoint
During treatment and two weeks after treatment
Method of measurement
Registration in the patient's self-report questionnaire
2
Description
Acceptance of medication
Timepoint
During treatment and two weeks after treatment
Method of measurement
Registration in the patient's self-report questionnaire
Intervention groups
1
Description
Intervention group: Administration of amoxicillin 1000 mg every 12 hours, moxifloxacin 400 mg every 12 hours, and pantoprazole 40 mg every 12 hours for 10 days, followed by pantoprazole at a dose of 40 mg every twelve hours for four weeks.
Category
Treatment - Drugs
2
Description
Control group: Administration of clarithromycin 500 mg every 12 hours, amoxicillin 1000 mg every 12 hours, bismuth subcitrate 240 mg every 12 hours and pantoprazole 40 mg every 12 hours for 10 days, followed by pantoprazole at a dose of 40 mg every twelve hours. The watch lasts for four weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital of Ahvaz
Full name of responsible person
Amir hooshang bavarsad
Street address
Imam Khomeini Hospital ,24 Meter Street
City
Ahwaz
Province
Khouzestan
Postal code
۶۱۹۳۶۷۳۱۶۶
Phone
+98 61 3222 2114
Email
himam@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh zakerkish
Street address
Vice President of Research and Technology Development ,Esfand St., Jundishapur University of Medical Sciences, Golestan Blvd ,Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3314 0000
Email
info@ajums.ac.ir
Web page address
https://www.ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Amir hooshang bavarsad
Position
Assistant specialist in gastroenterology and liver for adults
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 8, Mehr East Street, Kianpars Street
City
Ahvaz
Province
Khouzestan
Postal code
6155635999
Phone
+98 61 3333 4663
Email
a.bavarsad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir hooshang bavarsad
Position
Gastroenterology and hepatology assistant for adults
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 8, Mehr East Street, Kianpars Street
City
Ahvaz
Province
Khouzestan
Postal code
6155635999
Phone
+98 61 3333 4663
Email
a.bavarsad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Amir hooshang bavarsad
Position
Gastroenterology and hepatology assistant for adults
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
No. 8, Mehr East Street, Kianpars Street
City
Ahvaz
Province
Khouzestan
Postal code
6155635999
Phone
+98 61 3333 4663
Email
a.bavarsad@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available