The effect of omeprazole and es-omeprazole on infants under one year old with reflux disease
Design
Clinical trial with control group, with parallel group, double-blind, non-randomized groups
Settings and conduct
All infants under one year of age referred to gastrointestinal clinics of Kashan city in year 1398 will receive reflux disease based on medical history and clinical examination and will be prescribed omeprazole and es-omeprazole for their treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
1) Infants 1 to 11 months of age with clinical diagnosis of GERD based on symptoms or endoscopic evidence.
Exclusion criteria:
1) Using a PPI in the last 7 days.
2) Treatment for reflux symptoms, including histamine 2 receptor antagonists, procinetics, and bismuth-containing antacids within 24 hours before intervention.
3) Patients with active gastrointestinal bleeding, apnea, allergic gastroenteritis, eosinophilic gastroenteritis, bleeding disorders, pyloric stenosis, active seizure disorder, acute pancreatitis or meningitis.
Intervention groups
Omeprazole and S-omeprazole 0.25 mg / kg in infants under one year with reflux inclusion criteria for 4 weeks.
Main outcome variables
Age
Sex
Weight
Measuring time
Intervention group
Recovery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191027045256N1
Registration date:2020-03-09, 1398/12/19
Registration timing:retrospective
Last update:2020-03-09, 1398/12/19
Update count:0
Registration date
2020-03-09, 1398/12/19
Registrant information
Name
Mohamad Ali Sabahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3291 7528
Email address
alisabahi1369@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2019-11-16, 1398/08/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of treatment with omeprazole and es-omeprazole in reflux disease (GERD) infants Lesser than one year old
Public title
effect of omeprazole and es-omeprazole in reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infants 1 to 11 months of age with clinical diagnosis of reflux based on symptoms or endoscopic evidence
Exclusion criteria:
Using a PPI in the last 7 days
Treatment for reflux symptoms, including histamine 2 receptor antagonists, procinetics, and bismuth-containing antacids within 24 hours before intervention
Patients with active gastrointestinal bleeding, apnea, allergic gastroenteritis, eosinophilic gastroenteritis, bleeding disorders, pyloric stenosis, active seizure disorder, acute pancreatitis or meningitis
Age
From 1 month old to 11 months old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients will be randomly assigned to receive an oral dose of these two drugs at random for four weeks, in which participants, parents, caregivers, researchers, and pharmacists will be blinded to treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Approval date
2019-10-06, 1398/07/14
Ethics committee reference number
IR.KAUMS.REC1398037
Health conditions studied
1
Description of health condition studied
GERD
ICD-10 code
K21.9
ICD-10 code description
Gastro-esophageal reflux disease without esophagitis
Primary outcomes
1
Description
Effect of Omeprazole and S-Omeprazole in Children
Timepoint
Symptoms evaluated included vomiting, contractility, irritability, hyper-esophageal and respiratory disorders (eg cough, wheezing / steroids) and nutritional problems (eg, dizziness / choking). 1 hour will be defined. Vomiting / regurgitation volume will be classified as small (5-15 ml), medium (15-30 ml), large (more than 30 ml) at any time of 4 weeks.
Method of measurement
Recovery involves reducing the severity of symptoms to more than half of the initial symptom score (before the intervention).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Esomeprazole Abidi company,
Category
Treatment - Drugs
2
Description
Intervention group 1: eprazole Abidi company
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Seyed Ramin Madani
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5557 8010
Email
alisabahi1369@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed ramin Madani
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5557 8010
Email
drraminmadani@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mohamadali Sabahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5557 8010
Email
alisabahi1369@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Seyed Ramin Madani
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kashan University of Medical Sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5557 8010
Email
drraminmadani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohamadali Sabahi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Kashan university of medical sciences, Qotbe Ravandi Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
87159-81151
Phone
+98 31 5557 8010
Email
alisabah1369@gmail.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