Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Information source: Eli Lilly and Company
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Failure to Thrive
Intervention: Somatropin (rDNA origin) for injection (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Eli Lilly and Company Official(s) and/or principal investigator(s):
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study Chair, Affiliation: Eli Lilly and Company
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 prepubertal patients with SHOX deficiency. Both groups will be compared to a
somatropin-treated group of girls with Turner syndrome. After the second year patients in the
control group have the option to receive treatment as well. All patients will optionally be
treated until they achieved adult height.
Clinical Details
Official title: Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
Study design: Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Secondary outcome: Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.Non inferiority to somatropin treated patients with Turner syndrome Adult height of treated patients
Eligibility
Minimum age: 3 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- GH deficiency or known insensitivity
- Evidence of tumor activity
- Diabetes mellitus or history of impaired glucose tolerance
- Any severe illness known to interfere growth
Locations and Contacts
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
Additional Information
Lilly Clinical Trial Registry
Starting date: February 2000
Ending date: December 2010
Last updated: October 18, 2007
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