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
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