A clinical trial to study the effects of two drugs, R-TPR-007 and Norditropin® Nordilet® in growth hormone deficient children
Phase 3
Active, not recruiting
- Conditions
- Growth hormone deficiency in children
- Registration Number
- CTRI/2015/06/005907
- Lead Sponsor
- Reliance Life Sciences Pvt Ltd
- 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. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
The primary outcome will assess the mean change in height at 6 months and 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in height at 6 months and 12 months. 6 months and 12 months from baseline, after start of the therapy
- Secondary Outcome Measures
Name Time Method Mean change in % weight increase at 6 months and 12 months Mean change in BMI at 6 months and 12 months
Trial Locations
- Locations (5)
Apollo Speciality Hospitals
🇮🇳Madurai, TAMIL NADU, India
Chennai Meenakshi Multispeciality Hospital
🇮🇳Chennai, TAMIL NADU, India
Getwell Hospital and Research
🇮🇳Nagpur, MAHARASHTRA, India
Jehangir clinical Development
🇮🇳Pune, MAHARASHTRA, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Apollo Speciality Hospitals🇮🇳Madurai, TAMIL NADU, IndiaDr Kumaravel VelayuthamPrincipal investigator9940582328drvkumaravel@gmail.com