Children aged 2-12 months with symptomatic gastroesophageal reflux disease (GERD) were recruited to randomized, parallel-group study. Symptoms were assessed for a minimum period of 48 hours before entry. Patients took standard treatment including frequent and small volume feeding, hypo allergic milk, thickening of feeds during 2 weeks. After 2 weeks if any patient had persistence symptoms, included in randomized study. 60 Patients were randomly assigned to the treatment group A (omeprazole1.2 mg/kg, 5 mg/day for infants 2.5 to 7 kilograms and 10 mg daily for infants to 7-15 kilograms) or group B (syrup of ranitidine with dose 2-4 mg/kg/day in divided 2 doses). Symptoms were assessed during the 2-week treatment period. A parent or guardian completed a symptom diary.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112135330N2
Registration date:2012-04-21, 1391/02/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-04-21, 1391/02/02
Registrant information
Name
Mandana Rafeey
Name of organization / entity
Liver and gastrointestinal research center, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1331 4135
Email address
rafieem@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-08-21, 1391/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of omeprazole and ranitidine in treatment of symptomatic gastroesophageal reflux disease in infants 2 -12 months old
Public title
Effect of omeprazole on the treatment of gastroesophageal reflux disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infants 2-12 months with body weight over 2.5 kg and full term pregnancy, who had GERD. Exclusion Criteria: Children with previous gastrointestinal surgery, neurologic disease, significant hepatic or renal impairment or a history of significant cardiac or respiratory disease, a history of peptic ulcer disease, proven lactose intolerance, or cow’s milk protein intolerance; All children hadn’t parental reassurance, use antacids, H2-antagonists, and proton pump inhibitors [PPIs] 4 week before study were excluded.
Age
From 2 years old to 12 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2011-08-21, 1390/05/30
Ethics committee reference number
4314/4/5
Health conditions studied
1
Description of health condition studied
Gastro-oesophageal reflux disease
ICD-10 code
K21.0
ICD-10 code description
Gastro-oesophageal reflux disease with oesophagitis
Primary outcomes
1
Description
weekly GERD symptom score (WGSS)
Timepoint
during 2 weeks
Method of measurement
sum of the 5 selected individual weekly GERD symptom mean frequencies for vomiting/regurgitation (1a), irritability/fussiness (2b), choking/gagging (3a), arching back (4a), and refusal to feed (higher score of 5a and 5b).
Secondary outcomes
1
Description
lack of efficacy per withdrawal criteria, growth parameter
Timepoint
week 4-8
Method of measurement
withdrawal for any reason, time to withdrawal due to lack of efficacy, time to withdrawal for any reason, weekly GERD symptom score (WGSS) ,Physical examinations
Intervention groups
1
Description
omeprazole granules for suspension approximately 1.2mg /kg/ day (5 mg/day for infants 2.5 kg to <7 kg, or 10 mg/day for infants 7kg to 15 kg) for 8 weeks. (Omeprazole is from Chemi daru pharmaceutical company)
Category
Treatment - Drugs
2
Description
syrup of ranitidine by dose 2-4mg/kg/day divided in two doses (ranitidine is from Chemi daru pharmaceutical company).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz children hospital
Full name of responsible person
Street address
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Ali Meshkini
Street address
Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz university of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Mandana Rafeey
Position
professor
Other areas of specialty/work
Street address
Children hospital, Shishgalan
City
Tabriz
Postal code
Phone
+98 411526225058
Fax
Email
mrafeey@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Mandana Rafeey
Position
professor
Other areas of specialty/work
Street address
Children hospital, Shishgalan
City
Tabriz
Postal code
Phone
+98 411526225058
Fax
Email
mrafeey@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Dr. Hamid Reza Azizollahi
Position
Resident
Other areas of specialty/work
Street address
Children hospital, Shishgalan
City
Tabriz
Postal code
Phone
+98 41 1332 8266
Fax
Email
azizollahih@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)