Trials / Unknown
UnknownNCT00837863
Study of Weekly ALTU-238 Compared With Daily Nutropin AQ in Prepubertal Children With Growth Hormone Deficiency
A Twelve Month, Phase II, Randomized, Open-Label, Multi-Center, Dose-Ranging Study of Weekly ALTU-238 (Somatropin) as Compared With Daily Nutropin AQ (Somatropin) in Prepubertal Children With Growth Hormone Deficiency
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Altus Pharmaceuticals · Industry
- Sex
- All
- Age
- 3 Years – 13 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the safety and effectiveness of ALTU-238 in the treatment of children with growth hormone deficiency who have not yet reached puberty who lack the normal ability to make growth hormone themselves. This study will also test if ALTU-238 works as a weekly treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Somatropin | ALTU-238 0.3 mg/kg daily |
| DRUG | Somatropin | ALTU-238 0.6 mg/kg daily |
| DRUG | Somatropin | ALTU-238 0.9 mg/kg daily |
| DRUG | Somatropin | Nutropin AQ 0.043 mg/kg daily |
Timeline
- Start date
- 2009-03-01
- Primary completion
- 2010-09-01
- First posted
- 2009-02-05
- Last updated
- 2009-05-07
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00837863. Inclusion in this directory is not an endorsement.