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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00097539
First received: November 24, 2004
Last updated: November 13, 2012
Last verified: November 2012
  Purpose

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.


Condition Phase
Growth Disorders
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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]

Resource links provided by NLM:


Further study details as provided by Genentech:

Enrollment: 58998
Study Start Date: October 1985
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097539

Sponsors and Collaborators
Genentech
Investigators
Study Director: Barbara Lippe, M.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00097539     History of Changes
Obsolete Identifiers: NCT00231361, NCT00672126
Other Study ID Numbers: 85-036
Study First Received: November 24, 2004
Last Updated: November 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
Pediatric growth disorders

Additional relevant MeSH terms:
Growth Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014