Growth Hormone Treatment in Short Children Born Small for Gestational Age
Phase 3
Completed
- Conditions
- Infant, Small for Gestational Age
- Registration Number
- NCT00191529
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Born small for gestational age
- actual body height less than or equal -3 SDS
- chronological age greater than 3 years
Exclusion Criteria
- Growth hormone deficiency
- any defined syndromal disease
- Diabetes mellitus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The 2 different doses used are non-inferior to each other
- Secondary Outcome Measures
Name Time Method Safety profiles Compare absolute height velocity
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie growth hormone receptor signaling in small for gestational age infants?
How does the OPTIMA trial compare growth hormone dosing to standard-of-care regimens for SGA-related short stature?
Which biomarkers correlate with growth response prediction models in NCT00191529 pediatric trials?
What adverse events are associated with high-dose growth hormone therapy in SGA children post-OPTIMA study?
How do GH analogs from Eli Lilly compare to other recombinant human growth hormone formulations in SGA treatment?
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇩🇪Koln, Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.🇩🇪Koln, Germany