- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00190658
Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome
December 17, 2010 updated by: Eli Lilly and Company
Safety and Efficacy of Humatrope in Pediatric Patients With Genetic Short Stature (SHOX Gene Defect)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
75
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, 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.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Comparison of first year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
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Secondary Outcome Measures
Outcome Measure |
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Comparison of second year height velocity of somatropin-treated versus non-treated patients with SHOX deficiency.
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Non inferiority to somatropin treated patients with Turner syndrome
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Adult height of treated patients
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2000
Primary Completion (ACTUAL)
July 1, 2004
Study Completion (ACTUAL)
September 1, 2010
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 19, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
December 20, 2010
Last Update Submitted That Met QC Criteria
December 17, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2704
- B9R-MC-GDFN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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