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CTRI Number  CTRI/2015/06/005907 [Registered on: 12/06/2015] Trial Registered Prospectively
Last Modified On: 26/07/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of two drugs, R-TPR-007 and Norditropin® Nordilet® in growth hormone deficient children 
Scientific Title of Study   Prospective, multi-centric, randomized, open-label, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of R-TPR-007/ Norditropin® Nordilet® in growth hormone deficient children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/TP/2012/02, version 3.0, dated 10th Jul 2014  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeev Hegde 
Designation  Head Clinical Development 
Affiliation  Reliance Life Sciences 
Address  Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  0224067000  
Fax  02240678299  
Email  sanjeev.hegde@relbio.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeev Hegde 
Designation  Head Clinical Development 
Affiliation  Reliance Lifesciences 
Address  Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Mumbai
MAHARASHTRA
400701
India 
Phone  0224067000  
Fax  02240678299  
Email  sanjeev.hegde@relbio.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jay Madkaikar 
Designation  Project Manager 
Affiliation  Reliance Lifesciences 
Address  Reliance Life Sciences Pvt.Ltd Dhirubhai Ambani Life Sciences Centre R-282 TTC Area of MIDC Rabale Mumbai Maharashtra 400701, India.

Thane
MAHARASHTRA
400701
India 
Phone  0224067000  
Fax  02240678299  
Email  jay.madkaikar@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt. Ltd. Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road, Rabale, Navi Mumbai 400 701. India  
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai 400 701. India.  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kumaravel Velayutham  Apollo Speciality Hospitals  Apollo Speciality Hospitals, Ground Floor, Department of Pediatric Endocrinology Lake View Road, K.K.Nagar Madurai 625020, Tamilnadu, India
Madurai
TAMIL NADU 
9940582328

drvkumaravel@gmail.com 
Dr Shriraam Mahadevan  Chennai Meenakshi Multispeciality Hospital  Meenakshi Multispeciality Hospital, Old 148, New 72, Luz Church Road,Mylopore, Chennai- 600004
Chennai
TAMIL NADU 
9840488777
044-24993282
mshriraam@gmail.com 
Dr Jayashri Shembalkar  Getwell Hospital and Research   Getwell Hospital & Research Institute, Department of Endocrinology. Ground Floor 20/1, Dr. Khare Marg Dhantoli Nagpur
Nagpur
MAHARASHTRA 
7126632200

pkshembalkar@hotmail.com 
DrAnuradha Khadilkar  Jehangir clinical Development   Jehangir clinical Development Centre Pvt Ltd.,Department of Pediatrics, Ground Floor Jehangir Hospital Premises, 32 Sasoon Road Pune 411001
Pune
MAHARASHTRA 
020-67268800

anuradhavkhadilkar@gmail.com 
Dr B Vivekanand  King George Hospital  Dept. Endocrinology, Superspecialty Block, First Floor, King George Hospital, Maharanipeta, Visakhapatnam - 530002 India
Visakhapatnam
ANDHRA PRADESH 
9440514756

kumarelk@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Chennai Meenakshi Hospital Ethics Committee  Approved 
Ethics Committee Apollo Speciality Hospitals  Approved 
IEC, Getwel Hospital and Research Institute, Nagpur  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Jehangir Clinical Development  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Growth hormone deficiency in children,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Norditropin® Nordilet®  Dose: 0.033 mg/kg/day (0.23 mg/kg/week), 7 times a week at night, Route Of Administartion: Subcutaneous, Duration:12 months 
Intervention  R-TPR-007   Dose 0.033mg/Kg/day (0.23mg/kg/week), 7 times a week at night Duration 12 months, Route of administration subcutaneous 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  Clinically suspected GH-naïve pre-pubertal children

Idiopathic growth hormone deficiency

Patients with ratio of bone age/chronological age of <0.9 with open epiphysis.

Patients who are euthyroid.

Parents willing to give informed consent and subject willing to give assent for the study.

Able to comprehend and willing to come for follow up visits as per protocol
requirement
 
 
ExclusionCriteria 
Details  Patients with a history of resistance to growth hormone therapy

Patients with any major systemic illness, and/or had known hypersensitivity to study
drug

Patients with active neoplasia or intracranial tumor at screening.

Growth retardation attributable to causes other than GHD

History of Intrauterine growth retardation.

Patients with history of administration of other growth-altering medications.

Patients with abnormal laboratory parameters

Patients who test positive for HIV, HBsAg, or HCV.

History of clinically significant diseases.

Patient participation in another clinical trial 30 days prior to administration of IP.

Any other condition which investigator feels would pose a significant hazard to the
patient, if IP is administered.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Mean change in height at 6 months and 12 months.  6 months and 12 months from baseline, after start of the therapy 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in % weight increase at 6 months and 12 months
Mean change in BMI at 6 months and 12 months
Mean change in bone age at 12 months
Change in IGF-1 levels.
Pharmacokinetic parameters and pharmacodynamics parameter
Evaluation of safety
Anti rhGH antibody assessments
 
6 months and 12 months from baseline, after start of the therapy 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/07/2015 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

This is a prospective, multi-centric, randomized, open-label, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy, safety, pharmacokinetics and pharmacodynamics of R-TPR-007/ Norditropin® Nordilet® in growth hormone deficient children.

 

The primary outcome will assess the mean change in height at 6 months and 12 months.

 
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