Status:
COMPLETED
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Lead Sponsor:
Eli Lilly and Company
Conditions:
Growth Disorder
Eligibility:
All Genders
9-16 years
Phase:
PHASE3
Brief Summary
After approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. In addition, patients who had discontinued early from the core, blinded phas...
Eligibility Criteria
Inclusion
- Participation in core, blinded phase and ability to be contacted by investigators.
- For patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. For patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls.
Exclusion
- Diabetes mellitus.
- History, evidence or signs of active malignancy within 5 years prior to the start of the extension phase.
- Any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00191074
Start Date
February 1 2001
End Date
January 1 2006
Last Update
March 9 2007
Active Locations (1)
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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.
Bethesda, Maryland, United States, 20892