Evaluation and comparison of the efficacy of 10-day versus 12-day concomitant therapy as the first-line treatment for H. pylori eradication in Iran.
Design
This is a randomized single-blind clinical trial with a control group. In this study, Two hundred patients with peptic ulcer disease and Helicobacter pylori infection who refer to Gastroenterology clinic of Imam Khomeini hospital of Sari, will enter the study. They will be divided into 2 groups with block randomization method. The first group will receive 10-ay and the second group will recieve 12-day concomitant regimen. Eight weeks after therapy, Helicobacter pylori eradication will be assessed by Urea breath test.
Settings and conduct
This is a single blind study, performed on 200 patients with peptic ulcer disease and Helicobacter pylori infection in Gastroenterology clinic of Imam Khomeini hospital of Sari. These patients are divided into 2 groups by block randomization method and then will be treated by either 10-day or 12-day concomitant regimen.
Participants/Inclusion and exclusion criteria
Two hundred patients with peptic ulcer disease and Helicobacter pylori infection according to pathologic assessment of gastric biopsy or rapid urease test, and no history of previous treatment for Helicobacter pylori eradication, will enter the study.
Intervention groups
The first group will receive 10-ay and the second group will recieve 12-day concomitant regimen composed of Pantoprazole 40 mg, Amoxicillin 1000 mg, Clarithromycin 500 mg and Metronidazole 500 mg, all given twice daily.
Main outcome variables
Helicobacter pylori eradication status
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170521034070N2
Registration date:2019-10-28, 1398/08/06
Registration timing:retrospective
Last update:2019-10-28, 1398/08/06
Update count:0
Registration date
2019-10-28, 1398/08/06
Registrant information
Name
Zohreh Bari
Name of organization / entity
Mazandaran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 153 6575
Email address
zbari@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-22, 1397/10/01
Expected recruitment end date
2019-09-22, 1398/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of 10-day vs. 12-day concomitant therapies for first-line Helicobacter pylori eradication in Iran.
Public title
Concomitant therapies for first-line Helicobacter pylori eradication
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with peptic ulcer disease according to endoscopic findings
Presence of Helicobacter pylori is proven in gastric tissue according to pathologic assessment of gastric biopsy
No history of previous treatment for Helicobacter pylori
Exclusion criteria:
Breast feeding
History of gastrointestinal surgery
History of gastrointestinal malignancy
using anticoagulant drugs
using anti convulsion drugs
pregnancy
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was used. So that patients were classified in 5-patients blocks according to their age and gender and the first five patients will enter the 10-day regimen group and the next five patients will enter the 12-day regimen group and this classification will be continued respectively until the total number of cases would be completed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The statistician is blind to the study groups.
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
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4816613135
Approval date
2018-06-11, 1397/03/21
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1397.031
Health conditions studied
1
Description of health condition studied
Gastric ulcer
ICD-10 code
K25
ICD-10 code description
Gastric ulcer
2
Description of health condition studied
Duodenal ulcer
ICD-10 code
K26
ICD-10 code description
Duodenal ulcer
Primary outcomes
1
Description
Helicobacter pylori eradication
Timepoint
Eight weeks after receiving the drugs, Helicobacter pylori eradication will be evaluated by Urea Breath test.
Method of measurement
Urea Breath test.
Secondary outcomes
empty
Intervention groups
1
Description
Patients in the intervention group will receive Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg and Metronidazole 500 mg (all given twice daily) for ten days.
Category
Treatment - Drugs
2
Description
Patients in the control group will receive Pantoprazole 40 mg, Amoxicillin 1g, Clarithromycin 500 mg and Metronidazole 500 mg (all given twice daily) for twelve days.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Zohreh Bari
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4816613135
Phone
+98 11 3377 1760
Email
zohreb252@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeidi
Street address
Moallem square
City
Sari
Province
Mazandaran
Postal code
4817844718
Phone
+98 11 3448 4800
Email
majsaeedi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Zohreh Bari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and hepatology
Street address
Amir Mazandarani street
City
Sari
Province
Mazandaran
Postal code
4816613135
Phone
+98 11 3377 1760
Email
zohreb252@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Bari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and hepatology
Street address
Amir Mazandarani
City
Sari
Province
Mazandaran
Postal code
4816613134
Phone
+98 11 3377 1760
Email
zohreb252@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Zohreh Bari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroenterology and hepatology
Street address
Amir Mazandarani
City
Sari
Province
Mazandaran
Postal code
4816613135
Phone
+98 11 3377 1760
Email
zohreb252@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
The results of this study about Helicobacter pylori eradication rate will be published after deidentification of the participants.
When the data will become available and for how long
immediately after being published
To whom data/document is available
There is no limitation.
Under which criteria data/document could be used
There is no limitation.
From where data/document is obtainable
There is no limitation.
What processes are involved for a request to access data/document
It will be according to guidelines of the journal that will publish the article derived from the results of this study.