National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients

This study has been completed.

First Received: November 24, 2004 Last Updated: July 14, 2008 History of Changes

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00097513

Purpose

This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.

Condition	Phase
Dwarfism, Pituitary	Phase IV

Study Type:	Observational
Study Design:	Prospective
Official Title:	National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: pseudoachondroplasia

MedlinePlus related topics: Dwarfism

Drug Information available for: Somatropin Somatotropin

U.S. FDA Resources

Further study details as provided by Genentech:

Study Start Date:	February 2003
Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	12 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
Ability to keep follow-up appointments throughout the study
Willingness to remain on therapy until epiphyseal closure is achieved
Prior enrollment in NCGS Core Study 85-036

Exclusion Criteria:

Treatment with non-Genentech GH preparation
Closed epiphyses
Active neoplasia
Treatment with insulin for diabetes

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097513

Locations

United States, California
Genentech Central Contact
South San Francisco, California, United States, 94080

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Barbara Lippe, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	85-036, Substudy 12
Study First Received:	November 24, 2004
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00097513 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Genentech:

Pubertal Growth Hormone Deficiency

Additional relevant MeSH terms:

Dwarfism
Bone Diseases, Endocrine
Hypothalamic Diseases
Pituitary Diseases
Physiological Effects of Drugs
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Central Nervous System Diseases

Dwarfism, Pituitary
Brain Diseases
Hormones
Bone Diseases
Pharmacologic Actions
Musculoskeletal Diseases
Genetic Diseases, Inborn
Hypopituitarism
Bone Diseases, Developmental

ClinicalTrials.gov processed this record on November 20, 2009