1. Home
  2. Approved trials
  3. » فارسی

Comparison of the short & long term effects and side effects of Samen recombinant human growth hormone & NOVO growth hormone in children with growth hormone deficiency: double-blind randomized clinical trial study

Protocol summary

Summary
In this Randomized Clinical Trial, after randomization children to two groups for giving NOVO recombinant growth hormone or Samen recombinant growth hormone, we will evaluate children for 2 years. Our lababoratory tests include complete blood cell, blood urea nitrogen, creatinine,Na,potassium, insulin growth factor-1,Serum glutamic oxaloacetic transaminase,Serum glutamic pyruvic transaminase,alkaline phosphatase, phosphor,25-hydroxy vitamin D,bone age,height, weight, height standard deviation score, weight standard deviation score ,pubertal stage before starting study. We will repeat most of above exams in 1 month, 2 month, 3 month, 4month, 5 month, 6 month,12 month, 18 month, and finally in 24 month. We will record growth velocity in these times. Finally compare the results of these two groups and report them.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT1138901181414N11
Registration date: 2010-09-14, 1389/06/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-09-14, 1389/06/23
Registrant information
Name
Bagher Larijani
Name of organization / entity
Endocrinology & Metabolism Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 0037
Email address
emrc@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Samen Pharmaceutical Co. /Mashhad-Iran
Expected recruitment start date
2006-08-01, 1385/05/10
Expected recruitment end date
2011-08-01, 1390/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the short & long term effects and side effects of Samen recombinant human growth hormone & NOVO growth hormone in children with growth hormone deficiency: double-blind randomized clinical trial study
Public title
Comparison of the clinical & treatment effects of Samen recombinant human growth hormone & NOVO growth hormone in children with growth hormone deficiency
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: 1-Pre-pubertal stage 2-Height standard deviation score<-3 3-Insulin growth factor-1 inappropriate for age & sex (low) 4-Growth hormone level post stimulating test by clonidine <10 ng/ml 5-Rule out of the other causes of growth hormone deficiency exclusion criteria: 1-Acute disorders such as seizure, infection diseases 2-Turner syndrome 3-Chronic kidney disease 4-Usage prednisolone
Age
From 7 years old to 13 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 22
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
Endocrinology & Metabolism Research Center(EMRC) of TUMS
Street address
5th filoor,Dr.Sharati Hospital, North Karegar St.
City
tehran
Postal code
14114
Approval date
empty
Ethics committee reference number
E-0096

Health conditions studied

1

Description of health condition studied
Growth hormone deficiency in children
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Growth velocity
Timepoint
1 year
Method of measurement
assessment height, puberty status

Secondary outcomes

1

Description
Insulin growth factor-1,bone age
Timepoint
6 month
Method of measurement
blood sample, radiology

Intervention groups

1

Description
treatment intervention by 0.04 mg/kg/day Samen recombinant growth hormone in subcutaneous way for one year in intervention group
Category
Treatment - Drugs

2

Description
treatment intervention by daily subcutaneous injection 30 microgram/kilogram weight of NOVO recombinant growth hormone for one year in control group
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Endocrinology & Metabolism Research Center (EMRC) of TUMS
Full name of responsible person
Dr. Ozra Tabatabaei Malazy
Street address
5th floor, Dr. Sharati Hospital, North Karegar St.
City
tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Pharmacy CO. Samen
Full name of responsible person
Dr. Mohamad Ramezani
Street address
Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmacy CO. Samen
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr.Bagher Larijani
Position
Prof. Endocrinology
Other areas of specialty/work
Street address
5th floor, dr. Shariati Hospital, North Karegar st.
City
Tehran
Postal code
Phone
+98 21882200378
Fax
Email
emrc@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Endocrinology & Metabolism Research Center of Tehran University of Medical Sciences
Full name of responsible person
Dr. Ozra Tabatabaei Malazy
Position
Medical Doctor, Master of Public Health
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...