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Growth Hormone and Chromosome 18q- and Abnormal Growth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by The University of Texas Health Science Center at San Antonio.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
South Texas Veterans Health Care System
Genentech
Information provided by:
The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00134420
First received: August 22, 2005
Last updated: July 17, 2007
Last verified: July 2007
History of Changes
  Purpose

We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.


Condition Intervention Phase
Chromosome 18
Growth Hormone Deficiency
 Drug: Nutropin AQ
Procedure: Arginine and Clonidine Stimulation Testing
Procedure: Growth Factors Laboratory Testing
Procedure: Neuropsychological Testing
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Growth Hormone Trial for Children With 18q- and Abnormal Growth

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • growth rates 12-15 months after treatment begins

Secondary Outcome Measures:
  • performance IQ scores 12-15 months after treatment begins

Estimated Enrollment: 20
Study Start Date: February 2001
Estimated Study Completion Date: June 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of chromosome 18 deletion (cytogenetics report)
  • Children with abnormal growth but who are not classically growth hormone deficient

Exclusion Criteria:

  • Children previously on growth hormone therapy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134420

Locations
United States, Texas
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229-3900
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
South Texas Veterans Health Care System
Genentech
Investigators
Principal Investigator: Daniel E. Hale, M.D. The University of Texas Health Science Center at San Antonio
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00134420     History of Changes
Other Study ID Numbers: 300-C07
Study First Received: August 22, 2005
Last Updated: July 17, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center at San Antonio:
Growth Hormone
Chromosomes, Human, Pair 18
Child

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Clonidine
Mitogens
 Hormones
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013