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A Study to Evaluate Growth in Participants Treated With Somatropin (Nutropin) Using NuSpin Device

This study has been terminated.
(The study was closed due to the slow enrollment rate.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01243892
First Posted: November 19, 2010
Last Update Posted: December 1, 2016
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.
Information provided by (Responsible Party):
Genentech, Inc.
  Purpose
This is a Phase IV, open label, case-controlled, observational study to evaluate the age-adjusted cumulative height velocity in pre-pubertal isolated growth hormone deficient (IGHD) and idiopathic short stature (ISS) participants receiving daily doses of somatropin (recombinant human growth hormone [rhGH]; Nutropin) using NuSpin device compared to historical controls from the national cooperative growth study (NCGS).

Condition Intervention
Growth Hormone Deficiency Device: NuSpin Drug: Somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV, Open Label, Multicenter, Case-controlled Study of Growth in Patients Using the Nutropin AQ® Nuspin®

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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) ]
    The annualized height velocity (cm per year [cm/yr]) over 2 years was calculated as: [(height in cm at t24 minus (-) height in cm at t0) divided by (date at t24 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t24 is the 2-year measurement visit.


Secondary Outcome Measures:
  • 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) ]
    The annualized height velocity (cm/yr) after 1 year was calculated as: [(height in cm at t12 - height in cm at t0) divided by (date at t12 - date at t0)] multiplied by 365.25, where, t0 is the baseline measurement visit and t12 is the 1-year measurement visit.

  • 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) ]
    The annualized height velocity (cm/yr) for second year was calculated as: [(height in cm at t24 - height in cm at t12) divided by (date at t24 - date at t12)] multiplied by 365.25, where, t12 is the 1-year measurement visit and t24 is the 2-year measurement visit.


Enrollment: 18
Study Start Date: November 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Device: NuSpin
Device for administration of doses of somatropin.
Drug: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Name: Nutropin AQ (Somatropin [DNA Origin] injection)
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.
Device: NuSpin
Device for administration of doses of somatropin.
Drug: Somatropin
Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
Other Name: Nutropin AQ (Somatropin [DNA Origin] injection)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Somatropin-naive pre-pubertal participants with growth hormone deficiency or ISS
Criteria

Inclusion Criteria:

  • Bone age less than or equal to (</=) 8 years (females) or </= 10 years (males) as 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) </= -1.5 (</= 5th percentile) for IGHD participants; Ht SDS </= -2.25 (</= 1.2 percentile) for ISS participants

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
  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): NCT01243892


Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, Arizona
Scottsdale, Arizona, United States, 85258
United States, California
Sacramento, California, United States, 95819
San Diego, California, United States, 92123
United States, Colorado
Greenwood Village, Colorado, United States, 80111
United States, Florida
Palm Bay, Florida, United States, 32905
Pembrook Pines, Florida, United States, 33028
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Wheaton, Illinois, United States, 60187
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Mount Kisco, New York, United States, 10549
New Rochelle, New York, United States, 10801
United States, Ohio
Columbus, Ohio, United States, 43235
United States, Tennessee
Knoxville, Tennessee, United States, 37916
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: D. Aaron Davis, M.D. Genentech, Inc.
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01243892     History of Changes
Other Study ID Numbers: L4917g
ML01311 ( Other Identifier: Hoffmann-La Roche )
First Submitted: November 17, 2010
First Posted: November 19, 2010
Results First Submitted: October 7, 2016
Results First Posted: December 1, 2016
Last Update Posted: December 1, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Dwarfism, Pituitary
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
Endocrine System Diseases