N/A
N=65,205
National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin
Growth Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00097539 ↗Enrolled (actual)
65,205
Serious AEs
2.4%
Results posted
Feb 2017
Primary outcome: Primary: Number of Participants Who Died — 14; 96; 4; 7 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Somatrem (Biological); Somatropin (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Genentech, Inc.
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Died |
14; 96; 4; 7; 23; 38 | — |
| PRIMARY First Year Annualized Growth Rate |
9.5; 10.3; 8.6; 8.9; 9.5; 9.8 | — |
| PRIMARY Second Year Annualized Growth Rate |
7.7; 8.0; 7.3; 7.2; 7.5; 7.7 | — |
| PRIMARY Third Year Annualized Growth Rate |
7.0; 7.1; 6.6; 6.2; 6.8; 6.5 | — |
| PRIMARY Near Adult Height (NAH) |
-0.9; -1.1; -1.2; -2.0; -2.0; -1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Participants with open epiphyses
- Children of either sex who are treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
- Participants who are willing to keep follow up appointments throughout the study participation
Exclusion Criteria
- Participants treated with a non-Genentech GH preparation
- Participants with closed epiphyses
- Participants with active neoplasia
Data sourced from ClinicalTrials.gov (NCT00097539). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.