Somatropin Treatment in Patients With SHOX Deficiency and Turner Syndrome

NCT00190658 | Completed Phase 3

• 2 other identifiers: 2704B9R-MC-GDFN
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Failure to Thrive

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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

Interventions

Somatropin (rDNA origin) for injection DRUG

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• GH deficiency or known insensitivity
• Evidence of tumor activity
• Diabetes mellitus or history of impaired glucose tolerance
• Any severe illness known to interfere growth

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Failure to Thrive

Interventions

Human Growth Hormone; WW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Short Chain Dehydrogenase-Reductases; NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases; Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes; Tumor Suppressor Proteins; Neoplasm Proteins; Proteins

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: February 1, 2000
• Primary Completion: July 1, 2004
• Study Completion: September 1, 2010
• Last Updated: December 20, 2010

Record last verified: 2010-12

Locations

US (1)