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Growth Hormone Treatment in Short Children Born Small for Gestational Age

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.
ClinicalTrials.gov Identifier: NCT00191529
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : June 15, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
Comparison of 2 different doses of human growth hormone treatment on change in height after 1 and 2 years of treatment.

Condition or disease Intervention/treatment Phase
Infant, Small for Gestational Age Drug: somatropin Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : December 2002
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones
Drug Information available for: Somatropin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The 2 different doses used are non-inferior to each other

Secondary Outcome Measures :
  1. Safety profiles
  2. Compare absolute height velocity

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: September 19, 2005    Key Record Dates
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