Growth Hormone Treatment in Short Children Born Small for Gestational Age

This study has been completed.

First Received: September 12, 2005 Last Updated: June 13, 2007 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00191529

Purpose

Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

Condition	Intervention	Phase
Infant, Small for Gestational Age	Drug: somatropin	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	Optimization of Growth Hormone Treatment in Short Children Born Small for Gestational Age Based on a Growth Prediction Model-The OPTIMA Trial

Resource links provided by NLM:

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

The 2 different doses used are non-inferior to each other

Secondary Outcome Measures:

Safety profiles
Compare absolute height velocity

Estimated Enrollment:	200
Study Start Date:	December 2002
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	3 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Born small for gestational age
actual body height less than or equal -3 SDS
chronological age greater than 3 years

Exclusion Criteria:

Growth hormone deficiency
any defined syndromal disease
Diabetes mellitus

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00191529

Locations

Germany
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Koln, Germany

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Chair:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-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 by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Jung H, Land C, Nicolay C, De Schepper J, Blum WF, Schönau E. Growth response to an individualized versus fixed dose GH treatment in short children born small for gestational age: the OPTIMA study. Eur J Endocrinol. 2009 Feb;160(2):149-56. Epub 2008 Nov 27.

Study ID Numbers:	6581, B9R-EW-GDGB
Study First Received:	September 12, 2005
Last Updated:	June 13, 2007
ClinicalTrials.gov Identifier:	NCT00191529 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Belgium: Directorate general for the protection of Public health: Medicines; Netherlands: Medical Ethics Review Committee (METC); Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Hormones

ClinicalTrials.gov processed this record on September 02, 2009