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Growth Hormone Treatment in Short Children Born Small for Gestational Age

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00191529
First Posted: September 19, 2005
Last Update Posted: June 15, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Eli Lilly and Company
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: June 15, 2007
Last Verified: June 2007

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs