| CTRI Number |
CTRI/2013/09/003957 [Registered on: 05/09/2013] Trial Registered Retrospectively |
| Last Modified On: |
30/08/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Evaluate the Comparitive Safety and Efficacy of Recombinant Human Growth Hormone (rhGH) of USV with Eutropin in the Treatment of Pre-pubertal Children (4 to 12 years) with Growth Hormone Deficency |
|
Scientific Title of Study
|
A prospective Phase III, Multicentre, Randomised, Open Label Study to Evaluate the Comparitive Safety and Efficacy of Recombinant Human Growth Hormone (rhGH) of USV with Eutropin in the Treatment of Pre-pubertal Children (4 to 12 years) with Growth Hormone Deficency |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| US/112/07 version 02, 29-04-08 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapil Arora |
| Designation |
Associate Manager |
| Affiliation |
Apothecaries Private Limited |
| Address |
579, Devli, East Sainik Farm
New Delhi
DELHI
110062
India |
| Phone |
01124502551 |
| Fax |
|
| Email |
kapil.arora@apothecaries.net |
|
Details of Contact Person
Scientific Query
|
| Name |
Kapil Arora |
| Designation |
Associate Manager |
| Affiliation |
Apothecaries Private Limited |
| Address |
579, Devli, East Sainik Farm
New Delhi
DELHI
110062
India |
| Phone |
01124502551 |
| Fax |
|
| Email |
kapil.arora@apothecaries.net |
|
Details of Contact Person
Public Query
|
| Name |
Kapil Arora |
| Designation |
Associate Manager |
| Affiliation |
Apothecaries Private Limited |
| Address |
579, Devli, East Sainik Farm
New Delhi
DELHI
110062
India |
| Phone |
01124502551 |
| Fax |
|
| Email |
kapil.arora@apothecaries.net |
|
|
Source of Monetary or Material Support
|
| USV Ltd.
BSD Marg, Govandi,
Mumbai 400088, India |
|
|
Primary Sponsor
|
| Name |
USV Ltd |
| Address |
BSD Marg, Govandi, Mumbai 400088, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Apothecaries Private Limited |
579, Devli, East Sainik Farm, New Delhi-110062 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rajesh Khadgawat |
All India Institute of Medical Science |
pediatrics department, Ansari Nagar,-110029
New Delhi
DELHI |
9868397605
rajeshkhadgawat@hotmail.com |
| Dr AP Dubey |
Department of Paediatrics, |
Maulana Azad Medical College,-110002
New Delhi
DELHI |
9968604303
apdubey52@rediffmail.com |
| Dr IPS kochar |
Dr. IPS Kochar clinic |
D-121, Sector 40, Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9910240919
inderpal_kochar@yahoo.com |
| Dr Uday Phadke |
Instride Research Institute |
6 Poonam Arcade, Next to Hotel Surbhi ,-411034
Pune
MAHARASHTRA |
09623452969
uday.instride@gmail.com |
| Dr Sciddhartha Koonwar |
MV Hospital and Research Centre |
314/30, Mirza Mandi Chowk,-226003
Lucknow
UTTAR PRADESH |
09415102691
dr_sciddhartha@indiatimes.com |
| Dr VK Goel |
Panchsheel Hospital |
C-3/64, Yamuna Vihar,-110053
New Delhi
DELHI |
9810106800
vkgoyal22@gmail.com |
| Dr Warad Vijay Prabhuappa |
Shree Sai Childrens Hospital |
1st Floor, Baba Construction Building,-411043
Pune
MAHARASHTRA |
09822436184
vijaypwarad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Biomedical Ethic Committee/ Idependent Ethics Committee/ New Delhi/ Dr. Warad Vijay Prabhuappa/ 06 |
Approved |
| Biomedical Ethics Committee/ Independent Ethics Committee/ New Delhi/ Dr. IPS KOCHHAR/ 03 |
Approved |
| DIACARE research Ethics committee/ Intitutional Ethics Committee/ Ahmehdabad/ Banshi Saboo/ 08 |
Approved |
| Ethics Committee INSTRIDE/ Institutional Ethcis Committee/ Pune/ Uday Phadhke/ 07 |
Approved |
| Institutional Ethic Committee AIIMS / New Delhi /Site 01 Dr. Rajesh Khagawat |
Approved |
| Maulana Azad Medical college isutitutional ethics committee / new Delhi/ A.P. Dubey/ 02 |
Approved |
| The Biomedical Ethics Committee/ Independent Ethics Committee / New Delhi/ V.K. Goel/ 04 |
Approved |
| The Biomedical Ethics Committee/ independent Ethics committee/ New Delhi/ Shidhartha Koonwar/ 05 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Growth hormone deficiency in pre-pubertal children(4 to 12 years)., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LG Eutropin(Somatropin) |
Total weekly dose of 0.24mg/kg body weight administered in equal doses,subcutaneously,for 6 months |
| Intervention |
USV's Somatropin |
Total weekly dose of 0.24mg/kg body weight administered in equal doses,subcutaneously,for 6 months. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Pre-pubertal children in the age group of 4-12 years of age.
2. Children with short stature with a growth rate 5.0 cm per year.
3.Children with deficiency of GH testing without any organic pathology documented by dynamic GH testing by at least 2 differnent stimuli.The post stimulation level of human GH should not be / 10 ng/ml.
4. GH defiency if due to pituitary surgery not earlier than 2 years and woth a stable disease. |
|
| ExclusionCriteria |
| Details |
1.Associated endocrine disorders of thyroid function, adenocortical insufficiency(serum basal cortisol<3ug/dl) unless adequately replaced with thyroxin and showing a stable thyroid function at least for 8 weeks.
2.patients already receiving rhGH treatment
3. Known hypersenitivity to the Investigational products
4.Any systemic disorder likely to affect pharmacological action of somatropin. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) Height
2) Height Standard Deviation Score 3) Height Velocity
4) Height Velocity Standard Deviation Score |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) Insulin-like Growth Factor-1
2) Insulin-like Growth Factor-Binding Protein-3 |
Measured at 0,3 and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Prospective Phase III,Multicentre,randomized,Open label study to evaluate the comparative safety and efficacy of Recombinant Human Growth Hormone of USV with Eutropin in the treatment of Pre-pubertal children(4-12 years) with growth hormone deficiency.The Primary outcome measures will be Height,Height standard deviation score,height velocity and height velocity standard deviation score after 6 months.The secondary outcome will be measuring Insulin-like Growth Factor and Insulin-like Growth Factor-Binding Protein at 0,3 and 6 months. |