Trials / Terminated
TerminatedNCT01243892
A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 18 (actual)
- Sponsor
- Genentech, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone \[rhGH\]; Nutropin) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NuSpin | Device for administration of doses of somatropin. |
| DRUG | Somatropin | Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing. |
Timeline
- Start date
- 2010-11-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2010-11-19
- Last updated
- 2016-12-01
- Results posted
- 2016-12-01
Locations
14 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01243892. Inclusion in this directory is not an endorsement.