Back to resultsAmendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Primary Purpose
Growth Disorder
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 Growth Disorder
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
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
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.
Secondary Outcome Measures
Not applicable for Amendment (g).
Full Information
NCT ID
NCT00191074
First Posted
September 12, 2005
Last Updated
March 7, 2007
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00191074
Brief Title
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
Official Title
Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
somatropin, rDNA origin, for injection
Primary Outcome Measure Information:
Title
Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Title
Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
Title
laboratory blood draws.
Secondary Outcome Measure Information:
Title
Not applicable for Amendment (g).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
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 Director
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
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature
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