A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
NCT ID: NCT01243892
Last Updated: 2016-12-01
Study Results
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View full resultsBasic Information
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TERMINATED
18 participants
OBSERVATIONAL
2010-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: IGHD participants
Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid \[DNA\] origin) (recombinant human growth hormone \[rhGH\]) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.
NuSpin
Device for administration of doses of somatropin.
Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Cohort 2: ISS participants
Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, will be observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen will be as per treating physician's discretion, the study protocol does not enforce or specify any treatment regimen.
NuSpin
Device for administration of doses of somatropin.
Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Interventions
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NuSpin
Device for administration of doses of somatropin.
Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prepubertal males and females by physical exam
* Naive to rhGH therapy
* Diagnosis of IGHD or ISS by standard pharmacologic testing and no other discernable etiology for short stature
* Height standard deviation score (Ht SDS) \</= -1.5 (\</= 5th percentile) for IGHD participants; Ht SDS \</= -2.25 (\</= 1.2 percentile) for ISS participants
Exclusion Criteria
* Participants receiving chronic corticosteroid therapy (greater than \[\>\] 3 months) for other medical conditions
* Participants with active malignancy or any other condition that the investigator believes would pose a significant hazard to the participant if rhGH were initiated
* Females with turner syndrome
* Any previous rhGH treatment
* Participation in another simultaneous medical investigation or trial
* Pediatric participants with closed epiphyses
* Participants prescribed rhGH doses outside the variance of NCGS control participant dosing
2 Years
14 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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D. Aaron Davis, M.D.
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Birmingham, Alabama, United States
Scottsdale, Arizona, United States
Sacramento, California, United States
San Diego, California, United States
Greenwood Village, Colorado, United States
Palm Bay, Florida, United States
Pembrook Pines, Florida, United States
Atlanta, Georgia, United States
Wheaton, Illinois, United States
Minneapolis, Minnesota, United States
Mount Kisco, New York, United States
New Rochelle, New York, United States
Columbus, Ohio, United States
Knoxville, Tennessee, United States
Countries
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Other Identifiers
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ML01311
Identifier Type: OTHER
Identifier Source: secondary_id
L4917g
Identifier Type: -
Identifier Source: org_study_id