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

This study has been completed.

First Received: September 12, 2005 Last Updated: March 7, 2007 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191074

Purpose

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	Intervention	Phase
Growth Disorder	Drug: somatropin, rDNA origin, for injection	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase III Study of Humatrope in Non-Growth Hormone Deficient Children With Short Stature

Resource links provided by NLM:

MedlinePlus related topics: Growth Disorders

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

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).

Estimated Enrollment:	11
Study Start Date:	February 2001
Estimated Study Completion Date:	January 2006

Eligibility

Ages Eligible for Study:	9 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191074

Locations

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

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

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	843, B9R-MC-GDCH
Study First Received:	September 12, 2005
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00191074 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Growth Disorders
Hormones

Additional relevant MeSH terms:

Pathologic Processes
Growth Disorders

ClinicalTrials.gov processed this record on September 02, 2009