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NCT00097539 Clinical Trial

A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin

Growth Disorders Clinical Trial

Official title:
Genentech National Cooperative Growth Study (NCGS) Postmarketing Surveillance Program for Nutropin AQ [Somatropin (rDNA Origin) Injection], Nutropin [Somatropin (rDNA Origin) for Injection], and Protropin [Somatrem for Injection]

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00097539
Other study ID # 85-036
Secondary ID
Status Completed
Phase Phase 4
First received November 24, 2004
Last updated November 13, 2012
Start date October 1985
Est. completion date July 2010

Study information
Verified date November 2012
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

This study is a multicenter, open label, observational, postmarketing surveillance study of Nutropin AQ, Nutropin, and Protropin in the United States and Canada. This study (and subsequent substudies) were developed to investigate specific aspects of growth hormone (GH) treatment.

Other known NCT identifiers
  • NCT00231361
  • NCT00672126

Recruitment information / eligibility
Status Completed
Enrollment 58998
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Children of either sex who are treated with Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure

- Subjects who are willing to keep follow up appointments throughout study participation

Exclusion Criteria:

- Subjects treated with a non-Genentech GH preparation

- Subjects with closed epiphyses

- Subjects with active neoplasia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Genentech, Inc.
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