Trials / Completed
CompletedNCT00600808
Sustained Release Formulation of Somatropin (rDNA Origin)for Injection
A Phase II/IIIa, Assessor Blinded (Partially Blinded), Randomised, Active-Controlled, Multicentre, Parallel-Group Study of the Safety, Efficacy and pk/pd of LB03002 Administered Weekly in Children With Growth Failure Due to GH Deficiency.
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- BioPartners GmbH · Industry
- Sex
- All
- Age
- 4 Years – 10 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BPLG-003 |
Timeline
- Start date
- 2003-06-01
- Completion
- 2006-06-01
- First posted
- 2008-01-25
- Last updated
- 2008-01-25
Source: ClinicalTrials.gov record NCT00600808. Inclusion in this directory is not an endorsement.