Status:
COMPLETED
Pharmacodynamics of CNP During Growth Hormone Treatment
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
Children's Hospital Los Angeles
Novo Nordisk A/S
Conditions:
Pituitary Dwarfism
Idiopathic Short Stature
Eligibility:
All Genders
3+ years
Brief Summary
It is now widespread practice to treat children with short stature with growth hormone. However, how an individual child will respond to growth hormone treatment is unpredictable and highly variable. ...
Detailed Description
Treatment of children with short stature with recombinant human growth hormone is widespread practice. However, the growth response to growth hormone treatment is highly variable, particularly for tho...
Eligibility Criteria
Inclusion
- Age greater than 3 years
- Prepubertal
- Height SD score less than -2.25
- Had a growth hormone stimulation test
Exclusion
- History of any other disease or drug treatment that might interfere with linear growth, including amphetamine derivatives for treatment of ADD or ADHD
- Previous treatment with any growth-promoting medication, including growth hormone
- Any contraindication to growth hormone therapy
- Minor acute illness (upper respiratory infections, strep throat, gastroenteritis, urinary tract infection, etc.) less than one month prior to starting growth hormone
- Major acute illness (pneumonia, meningitis, pyelonephritis, any illness requiring hospitalization, etc.), any surgery, or bone fracture less than six months prior to starting growth hormone
- Weight less than 13 kg (NCC-J) or 15 kg (CHLA), due to blood volume being drawn.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01504802
Start Date
November 1 2010
End Date
September 1 2014
Last Update
October 2 2014
Active Locations (2)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Nemours Children Clinic
Jacksonville, Florida, United States, 32207