Comparison of the efficacy of 14- day concomitant regimen with 14- day high dose esomeprazole and amoxicillin regimen on Helicobacter pylori eradication
Comparison of the efficacy of 14-day concomitant and 14-day high-dose dual therapy on Helicobacter pylori eradication
Design
Phase 3 randomized clinical trial with control group, on 240 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. 240 patients, accoeding to inclusion & exclusion criteria enrolad the study. randomization are according to random table was extracted from internet
Participants/Inclusion and exclusion criteria
Inclusion 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
Group receiving high doses of PPI and amoxicillin
Main outcome variables
Success rate of this regimen in eradicating Helicobacter pylori, patient tolerance, drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131124015510N4
Registration date:2021-06-11, 1400/03/21
Registration timing:retrospective
Last update:2021-06-11, 1400/03/21
Update count:0
Registration date
2021-06-11, 1400/03/21
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
2020-05-09, 1399/02/20
Expected recruitment end date
2021-05-10, 1400/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of 14- day concomitant regimen with 14- day high dose esomeprazole and amoxicillin regimen on Helicobacter pylori eradication
Public title
Comparison of quadruple therapy and high dose dual therapy on Helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria was ages between 18 and 80 years who have H. pylori positive 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.
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
First, we use a Random Number Generator to extract 240 random numbers from one to 240.
These 240 extracted numbers include 1 and 2, which are arranged randomly and then the first number of patients are included in the study
Number 1 receives the standard regimen and number 2 receives the study regimen.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who include the the study would be blind
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
moallem
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2020-04-22, 1399/02/03
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1399.7090
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 infection
Timepoint
In the beginning of the study when patient enrolled the study
Method of measurement
Evaluation of Helicobacter pylori infection by RUT test or pathology
Secondary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
Six to 8 weeks after end of HP eradication treatment
Method of measurement
H pylori stool antigen test
Intervention groups
1
Description
Control group: Patients receiving the standard 14-day Helicobacter pylori eradication regimen
Category
Treatment - Drugs
2
Description
Intervention group: Patients receiving 14 days high-dose PPI and amoxicillin regimens for Helicobacter pylori eradication
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Toba clinic of Sari city
Full name of responsible person
Seyed Mohammad Valizadeh Toosi
Street address
Khazar bolvard
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 sayedi
Street address
Moallem
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 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
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 Mazandaran University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amir mazandarani, Immam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
0113335o670
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 Mohammad Valizadeh Toosi
Position
Assistant Professor Mazandaran University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Amir mazandarani, Immam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3335 0670
Email
seyedmohammadv@yahoo.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