Trials / Completed
CompletedNCT00191074
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 11 (planned)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 9 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phase of the study were contacted. All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | somatropin, rDNA origin, for injection |
Timeline
- Start date
- 2001-02-01
- Completion
- 2006-01-01
- First posted
- 2005-09-19
- Last updated
- 2007-03-09
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00191074. Inclusion in this directory is not an endorsement.