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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00097513
First received: November 24, 2004
Last updated: November 11, 2010
Last verified: November 2010
History of Changes
  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 4

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

MedlinePlus related topics: Dwarfism
Drug Information available for: Somatropin
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
Sampling Method:   Probability Sample
Study Population

Pubertal Growth Hormone Deficiency

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: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097513     History of Changes
Other Study ID Numbers: 85-036, Substudy 12
Study First Received: November 24, 2004
Last Updated: November 11, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
Pubertal Growth Hormone Deficiency

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases
Bone Diseases, Endocrine
Hypopituitarism
 Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013