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NCT00190658 Clinical Trial

Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

Failure to Thrive Clinical Trial

Official title:
Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00190658
Other study ID # 2704
Secondary ID B9R-MC-GDFN
Status Completed
Phase Phase 3
First received September 12, 2005
Last updated December 17, 2010
Start date February 2000
Est. completion date September 2010

Study information
Verified date December 2010
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date September 2010
Est. primary completion date July 2004
Accepts healthy volunteers No
Gender Both
Age group 3 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Somatropin (rDNA origin) for injection

Locations
Country Name City State
United States 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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Secondary Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Secondary Non inferiority to somatropin treated patients with Turner syndrome
Secondary Adult height of treated patients
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