Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00190658

Purpose

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.

Condition	Intervention	Phase
Failure to Thrive	Drug: Somatropin (rDNA origin) for injection	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)

Resource links provided by NLM:

Genetics Home Reference related topics: Turner syndrome Help Me Understand Genetics

MedlinePlus related topics: Turner Syndrome

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.

Secondary Outcome Measures:

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

Estimated Enrollment:	75
Study Start Date:	February 2000
Estimated Study Completion Date:	December 2010

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190658

Locations

United States, Pennsylvania
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Chair:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	2704, B9R-MC-GDFN
Study First Received:	September 12, 2005
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00190658 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Pathologic Processes
Failure to Thrive
Growth Disorders

ClinicalTrials.gov processed this record on February 08, 2010