Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
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|ClinicalTrials.gov Identifier: NCT00191074|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : March 9, 2007
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 phase of the study were contacted.
All of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.
|Condition or disease||Intervention/treatment||Phase|
|Growth Disorder||Drug: somatropin, rDNA origin, for injection||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||11 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature|
|Study Start Date :||February 2001|
|Study Completion Date :||January 2006|
- Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
- Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
- laboratory blood draws.
- Not applicable for Amendment (g).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00191074
|United States, Maryland|
|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|
|Study Director:||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|