Clinical Trials Directory

Trials / Completed

CompletedNCT00097539

National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin

Genentech National Cooperative Growth Study (NCGS) Post-Marketing Surveillance Program For Nutropin AQ® (Somatropin [rDNA Origin] Injection), Nutropin® (Somatropin [rDNA Origin] for Injection), and Protropin® (Somatrem for Injection)

Status
Completed
Phase
Study type
Observational
Enrollment
65,205 (actual)
Sponsor
Genentech, Inc. · Industry
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.

Conditions

Interventions

TypeNameDescription
BIOLOGICALSomatrem
BIOLOGICALSomatropin

Timeline

Start date
1985-10-01
Primary completion
2010-06-01
Completion
2010-06-01
First posted
2004-11-25
Last updated
2017-02-15
Results posted
2017-02-15

Source: ClinicalTrials.gov record NCT00097539. Inclusion in this directory is not an endorsement.