Amendment (g) Unblinded Extension Phase of Somatropin in Patients With Idiopathic Short Stature

Growth Disorder Clinical Trial

Official title:

Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191074
• Other study ID #: 843
• Secondary ID: B9R-MC-GDCH
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 7, 2007
• Start date: February 2001
• Est. completion date: January 2006

Study information

• Verified date: March 2007
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dwarfism
• Growth Disorder
• Growth Disorders

Intervention

Drug:
• somatropin, rDNA origin, for injection

Locations

Country	Name	City	State
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.	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Every 6 months: physical exam, pubertal staging, height, weight, and adverse event collection.
Primary	Every year: arm span measurements, head circumference measurements, x-ray for bone age, and
Primary	laboratory blood draws.
Secondary	Not applicable for Amendment (g).

External Links

•   Lilly Clinical Trial Registry