Comparison of the effectiveness of proton pump inhibitor (PPI) alone and with the method of adding baclofen to proton pump inhibitor (PPI) in the treatment of patients with gastroesophageal reflux disease (GERD) aged 7 to 12 years
The effect of adding baclofen to proton pump inhibitor in the treatment of patients with gastroesophageal reflux disease aged 7 to 12 years
Investigating the differences in improving the quality of life of treated children in the two groups
Comparison of treatment complications in the two groups
Comparison of the questioned indices before and after treatment in the two groups
Design
Clinical trial is examined in two groups of patients (control-case). These two groups are 60 people, non-randomly selected in phase 4 without blinding
Settings and conduct
In this study, patients with gastroesophageal reflux disease referred to a pediatrician in the office and hospital are examined. In this study, the first group received omeprazole at a dose of 1 mg per kg body weight, the second group received omeprazole at a dose of 1 mg per kg body weight, and baclofen 0.15 mg per kg body weight, which patients were monitored.
The relevant reflux standard questionnaire is completed before starting treatment and two weeks after starting treatment.
Patients received treatment for 2 weeks and were evaluated for standardized indicators based on age before the intervention and two weeks after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Children 7-12 years with gastroesophageal reflux disease
No entry conditions:
Specific diseases: cerebral palsy, treated with seizure drugs
, Patients with gastrointestinal ulcers and IBD
Intervention groups
Intervention group: Children 7-12 years old with gastroesophageal reflux disease who go to the office or hospital and receive baclofen and proton pump inhibitor at the same time
Control group: Children 7-12 years old with gastroesophageal reflux disease who go to the office or hospital and receive proton pump inhibitor drug
Main outcome variables
Reflux
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210308050634N1
Registration date:2021-06-12, 1400/03/22
Registration timing:registered_while_recruiting
Last update:2021-06-12, 1400/03/22
Update count:0
Registration date
2021-06-12, 1400/03/22
Registrant information
Name
Vajiheh Modaresisaryazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 1830
Email address
drmodarressi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-24, 1400/03/03
Expected recruitment end date
2021-07-09, 1400/04/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of proton pump inhibitor (PPI) alone and with the method of adding baclofen to proton pump inhibitor (PPI) in the treatment of patients with gastroesophageal reflux disease (GERD) aged 7 to 12 years
Public title
Comparison of the effect of baclofen and proton pump inhibitors in patients with gastroesophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children 7-12 years with gastroesophageal reflux disease
Exclusion criteria:
Cases of specific diseases (cerebral palsy, treated with anticonvulsant drugs, patients with gastrointestinal ulcers and IBD)
Age
From 7 years old to 12 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
After fully explaining the process of studying to patients and obtaining informed consent from patients, patients enter one of the treatment groups selected by the physician.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Azad University of Medical Sciences, Yazd Branch
Street address
Alem Square,Safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Approval date
2020-06-24, 1399/04/04
Ethics committee reference number
IR.IAU.YAZD.REC.1399.033
Health conditions studied
1
Description of health condition studied
gastroesophageal reflux disease
ICD-10 code
K21
ICD-10 code description
Gastro-esophageal reflux disease
Primary outcomes
1
Description
Voice violence or difficulty speaking
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
2
Description
Heartburn or chest pain or sourness
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
3
Description
Clear the throat
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
4
Description
Coughing after eating or lying down
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
5
Description
Night cough
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
6
Description
Shortness of breath or suffocation
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
7
Description
Feeling of a lump in the throat that is not relieved by eating
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
8
Description
Sputum in the throat
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
9
Description
Hard swallowing of liquids and solids
Timepoint
Before the intervention and two weeks after the intervention
Method of measurement
Reflux Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: An omeprazole group with a dose of 1 mg per kg body weight and baclofen 0.15 mg per kg body weight when patients are monitored. Received therapeutic intervention and were evaluated before the intervention and two weeks after the end of the intervention in terms of standardized indicators based on age.
Category
Treatment - Drugs
2
Description
Control group: In this study, omeprazole was administered to the control group at a dose of 1 mg per kg body weight and patients were monitored.The relevant reflux standard questionnaire is completed before starting treatment and two weeks after starting treatment.Patients received treatment for 2 weeks and were evaluated for standardized criteria based on age before the intervention and two weeks after the intervention.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Social Security Hospital
Full name of responsible person
Dr. vajih Modarresi
Street address
Namaz Sq,Modarres Street,Yazd
City
Yazd
Province
Yazd
Postal code
6652565265
Phone
+98 35 3833 0756
Email
shohadakargar.hos@tamin.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Mohammadreza Mortazavizadeh
Street address
Alam Square,Safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
526526532
Phone
+98 35 3187 1000
Email
info@iauyazd.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Dr. vajih Modarresi
Position
Faculty of Islamic Azad University
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Alem Square,Safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3725 1830
Email
drmodarressi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. vajih Modarresi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Alem Square , Safaieh,Yazd
City
Yazd
Province
Yazd
Postal code
8915813135
Phone
+98 35 3833 0756
Email
drmodarressi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyedeh Maryam Bahrololoom
Position
Professional PhD student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No. 19 ,Erfan Alley 5,Motehari Street, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7514944591
Phone
007733581470
Email
maryambahrololoom@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
The data obtained from the study will be published in the form of an article.
When the data will become available and for how long
6 to 12 months
To whom data/document is available
Everyone in medicine
Under which criteria data/document could be used
To people who study gastroesophageal reflux disease
From where data/document is obtainable
Email to the person performing the project
What processes are involved for a request to access data/document
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