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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01243892 |
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Date of registration:
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17/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device
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Scientific title:
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A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin® |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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18 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01243892 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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D. Aaron Davis, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genentech, Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Bone age less than or equal to ( determined by x-ray of the left hand and wrist obtained within six months before
enrollment
- 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) participants; Ht SDS
Exclusion Criteria:
- Short stature etiologies other than IGHD or ISS
- 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
Age minimum:
2 Years
Age maximum:
14 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Hormone Deficiency
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Intervention(s)
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Device: NuSpin
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Drug: Somatropin
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Primary Outcome(s)
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Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device After Two Years of Treatment
[Time Frame: Baseline up to Month 24 (Year 2)]
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Secondary Outcome(s)
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Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device for First Year of Treatment
[Time Frame: Baseline up to Month 12 (Year 1)]
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Annualized Height Velocity in Response to rhGH Treatment Using the NuSpin Device During the Second Year of Therapy
[Time Frame: Month 12 to Month 24 (Year 1 to Year 2)]
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Secondary ID(s)
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ML01311
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L4917g
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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