National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65205 participants

Study Classification

OBSERVATIONAL

Study Start Date

1985-10-31

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.

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Detailed Description

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Conditions

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Growth Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants With Growth Disorders

Participants initiating therapy with Genentech GH products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) for the treatment of pediatric growth disorders as determined by their physician and who have consented to participate in the NCGS will be enrolled in the study and will be followed throughout their course of treatment, or until withdrawal from the NCGS.

Somatrem

Intervention Type BIOLOGICAL

Somatropin

Intervention Type BIOLOGICAL

Interventions

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Somatrem

Intervention Type BIOLOGICAL

Somatropin

Intervention Type BIOLOGICAL

Other Intervention Names

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Protropin Nutropin®, Nutropin AQ®, Nutropin Depot™

Eligibility Criteria

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Inclusion Criteria

* Participants with open epiphyses
* Children of either sex who are treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
* Participants who are willing to keep follow up appointments throughout the study participation