Sustained Release Formulation of Somatropin (rDNA Origin)for Injection

Status Completed

Clinical Trial Summary

Annualised height velocity after 12/24 months treatment and HV SDS height velocity after 12/24 months treatment expressed as number of standard deviations difference from the mean population height velocity for the appropriate gender and chronological age.

Clinical Trial Description

To evaluate the safety, efficacy and pharmacokinetics/ pharmacodynamics of LB03002 in the treatment of growth failure in children with growth hormone deficiency (GHD) and to determine the dose for a subsequent phase IIIb BPLG-004 study ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00600808
Study type	Interventional
Source	BioPartners GmbH
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	June 2003
Completion date	June 2006

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See also
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