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

NCT01243892 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 18

Last updated 2016-12-01

Study results available
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Summary

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).

Conditions

  • Growth Hormone Deficiency

Interventions

DEVICE

NuSpin

Device for administration of doses of somatropin.

DRUG

Somatropin

Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • D. Aaron Davis, M.D. · Genentech, Inc.

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01243892 on ClinicalTrials.gov