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Comparing Efficacy and Safety of CinnaGen Biosimilar Growth Hormone (CinnaTropin®) Versus Nordilet in Children With Idiopathic Growth Hormone Deficiency

NCT03223025 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-08-31

No results posted yet for this study

Summary

This randomized, active-controlled, two-armed, open-label, and cross-over trial was designed to compare efficacy and safety of 0.03 mg/kg/day subcutaneous injections of either CinnaTropin® or Novo Nordisk growth hormone product in 30 children with Idiopathic Growth Hormone Deficiency. Patients were randomized to receive one of the products for three months. After that, each patient crossed over to the other arm to receive the other product for another three months. The primary objective of this study was to compare the efficacy of CinnaGen growth hormone (GH) with Nordilet. The secondary objectives of this study were further comparison and evaluation of efficacy along with safety between CinnaTropin® and Nordilet®.

Conditions

  • Idiopathic Growth Hormone Deficiency

Interventions

DRUG

CinnaTropin®

0.03 mg/kg daily subcutaneous injections

DRUG

Nordilet®

0.03 mg/kg daily subcutaneous injections

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-09
Primary Completion
2017-02-04
Completion
2017-02-04

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03223025 on ClinicalTrials.gov