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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 25, 2014