Comparison of the efficacy of 14-days high dose dual therapy and 14 days concomitant regimens as first line regimen for Helicobacter pylori eradication
Comparison of the effectiveness of a 14-day simultaneous diet with a 14-day high-dose diet of esmoprazole and emoxicillin on eradication of Helicobacter pylori
Design
Phase 3 randomized clinical trial with control group, on 210 patients with Helicobacter pylori infection
Settings and conduct
In this randomized clinical trial, among patients with symptoms of dyspepsia referred to the gastroenterology clinic of Toba in sari city in mazandaran province, upper GI endoscopy was done. 210 patients, accoeding to inclusion & exclusion criteria enrolad the study. randomization are according to random table was extracted from internet
Participants/Inclusion and exclusion criteria
nclusion criteria was ages between 18 and 80 years who have H. pylori infection and have endoscopic findings of gastric ulcer or erosion, duodenal ulcer or duodenitis and or histologic evidence of intestinal metaplasia. Exclusion criteria: Pregnant or nursing women, those with a history of upper GI surgery, major cardiac, lung, liver or renal diseases, a history of previous H. pylori eradication regimen and history of known side effects to the protocol drugs would be excluded from the study.
Intervention groups
The group receiving the high-dose two-drugs regimen of PPI and amoxicillin as the intervention group and the group receiving the concomitant quadreple therapy as the control group are included in the study.
Main outcome variables
Helicobacter pylori eradication rat, patient tolerance, drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015510N5
Registration date:2022-05-27, 1401/03/06
Registration timing:registered_while_recruiting
Last update:2022-05-27, 1401/03/06
Update count:0
Registration date
2022-05-27, 1401/03/06
Registrant information
Name
Seyed Mohammad Valizadeh Toosi
Name of organization / entity
Mazandaran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3320 2242
Email address
sm.valizadehtoosi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of 14-days high dose dual therapy and 14 days concomitant regimens as first line regimen for Helicobacter pylori eradication
Public title
Evaluation of the effectiveness of two- and four-drugs regimens in eradication of H pylori
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with peptic ulcer or gastro-duodenal erosion
Helicobacter pylori infection on a pathological biopsy or Rapid urease test
who have not previously received a Helicobacter pylori eradication regimen
Exclusion criteria:
Age under 18 years
Pregnancy and lactation
Concomitant use of anticoagulants, corticosteroids or ketoconazole
atients who have a history of gastric surgery
Patients with a confirmed history of severe heart or lung failure, chronic kidney failure, chronic liver disease or a history of cancer.
History of drug allergy to the drugs of this study
Previous history of Helicobacter pylori eradication
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
By using a Random Number Generator from web site of https://stattrek.com/statistics/random-number-generator.aspx , patients are randomly divided into two groups. First, I extract random numbers from the internet Equal to the number of patients to be included in the study. For example, in our study, 210 patients should be included in the study. First, a random number table is extracted from the Internet to the number of people entering the study, then, for example, number of one are assigned to the concomitant qudreple therapy group and two are assigned to the high-dose dual therapy regimen, and thus patients become random.
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 Mazandaran University of Medical Sciences
Street address
Imam Khomeini Hospital, Amir Mazandarani Ave.
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2022-03-16, 1400/12/25
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITALREC.1400.10588
Health conditions studied
1
Description of health condition studied
Peptic ulcer disease and H 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
Helicobacter pylori infection rat
Timepoint
Evaluation of Helicobacter pylori infection at the beginning of the study and then 8 weeks after receiving the desired treatment regimen
Method of measurement
Measurement of Helicobacter pylori infection variable by pathology at the beginning of the study and confirmation of eradication at the end of the study by fecal antigen method
Secondary outcomes
1
Description
H pylori infection eradication
Timepoint
initiation of study and 8 weeks after end of treatment
Method of measurement
At the beginning of treatment by pathology and at the end of treatment by fecal antigen of Helicobacter pylori
Intervention groups
1
Description
Intervention group: In this study, patients in the intervention group used esmoprazole capsules 40 mg three times a day and amoxicillin 500 mg capsules three times a day for 14 days.
Category
Treatment - Other
2
Description
Control group: In the control group, patients take esmoprazole 40 mg, amoxicillin 500 mg, metronidazole 500 mg and clarithromycin 500 mg one every 12 hours for 14 days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Toba Clinic
Full name of responsible person
Seyed Mohammad Valizadeh Toosi
Street address
Khazar Blvd
City
Sari
Province
Mazandaran
Postal code
4818911915
Phone
+98 11 3320 2242
Email
seyedmohammadv@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majed Saeedi
Street address
Moallem Ave
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3326 1244
Email
pajoheshi@mazums.ac.ir
Web page address
https://pajooheshi.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Valizadeh Toosi
Position
Assistant Professor,
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amire Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0672
Email
seyedmohammadv@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohammad Valizadeh Toosi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amir Maznandarani Ave
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Email
seyedmohammadv@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Seyed Mohamad Valizadeh Toosi
Position
Assistant Professor Mazandaran University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amir mazandarani,
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Email
seyedmohammadv@yahoo.com
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
no more information.
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
Yes - There is 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
Title and more details about the data/document
patients symptoms and H pylori infection status
When the data will become available and for how long
End of study
To whom data/document is available
Chief study desginer
Under which criteria data/document could be used
Study publishing
From where data/document is obtainable
Chief study desginer
What processes are involved for a request to access data/document