Status:
COMPLETED
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Lead Sponsor:
Eli Lilly and Company
Conditions:
Failure to Thrive
Eligibility:
All Genders
3+ years
Phase:
PHASE3
Brief Summary
This clinical trial will compare the mean first year height velocity of somatropin-treated prepubertal patients with SHOX deficiency with the height velocity of a control group of untreated prepuberta...
Eligibility Criteria
Inclusion
- Turner Syndrome or SHOX disorder
- SHOX: bone age greater than 10 years for boys, greater than 8 years for girls, Turner: bone age greater than 9 years
- Height below 3rd percentile or height below 10th percentile and growth velocity below 25th percentile
- Prepubertal: For girls, Tanner stage 1, for boys Tanner stage 1 and testicular volume no more than 2 mL
Exclusion
- GH deficiency or known insensitivity
- Evidence of tumor activity
- Diabetes mellitus or history of impaired glucose tolerance
- Any severe illness known to interfere growth
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
End Date :
September 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00190658
Start Date
February 1 2000
End Date
September 1 2010
Last Update
December 20 2010
Active Locations (1)
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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 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Philadelphia, Pennsylvania, United States