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Growth Hormone Treatment in Short Children Born Small for Gestational Age

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191529
First received: September 12, 2005
Last updated: June 13, 2007
Last verified: June 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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
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 ClinicalTrials.gov Identifier (NCT Number):

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

ClinicalTrials.gov processed this record on June 17, 2013