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

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT00191074

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Growth Disorder	Drug: somatropin, rDNA origin, for injection	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2001

Study Completion Date :

Jan 1, 2006

Outcome Measures

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). []

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 16 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Eli Lilly and Company

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Lilly Clinical Trial Registry

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00191074

Other Study ID Numbers:

843
B9R-MC-GDCH

First Posted:

Sep 19, 2005

Last Update Posted:

Mar 9, 2007

Last Verified:

Mar 1, 2007

Additional relevant MeSH terms:

Dwarfism

Growth Disorders

Study Results

No Results Posted as of Mar 9, 2007