Back to resultsSomatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Primary Purpose
Failure to Thrive
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Somatropin (rDNA origin) for injection
Sponsored by
About this trial
This is an interventional treatment trial for Failure to Thrive
Eligibility 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
Sites / Locations
- 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.
Outcomes
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
Full Information
NCT ID
NCT00190658
First Posted
September 12, 2005
Last Updated
December 17, 2010
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00190658
Brief Title
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
Official Title
Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
February 2000 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failure to Thrive
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Somatropin (rDNA origin) for injection
Primary Outcome Measure Information:
Title
Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Secondary Outcome Measure Information:
Title
Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
Title
Non inferiority to somatropin treated patients with Turner syndrome
Title
Adult height of treated patients
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Chair
Facility Information:
Facility Name
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.
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
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Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
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