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Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00567385
First received: November 30, 2007
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this trial is to evaluate the acceptance of the new liquid growth hormone formulation, somatropin, in children with growth hormone deficiency.


Condition Intervention Phase
Growth Hormone Disorder
Growth Hormone Deficiency in Children
 Drug: somatropin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency

Resource links provided by NLM:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Assessment of acceptance [ Time Frame: after 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Designated as safety issue: No ]
  • Adverse Events (AE) [ Designated as safety issue: No ]
  • Compliance [ Designated as safety issue: No ]

Enrollment: 176
Study Start Date: March 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Growth failure due to growth hormone insufficiency (GHD)
  • Turner syndrome: established diagnosis according to sex chromosome analysis, or
  • Growth retardation in children with chronic renal disorders

Exclusion Criteria:

  • Pregnancy
  • Breast feeding women
  • Suspected or know allergy to trial product
  • Participating in any other trial involving other investigational products within the last 3 months
  • Previous participation in the trial
  • Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00567385

Locations
Turkey
Altunizade-Istanbul, Turkey, 34662
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Asude Ademogullari, BSc Novo Nordisk Saglik Urunleri Tic. Ltd. St.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00567385     History of Changes
Other Study ID Numbers: GHLIQUID-1515
Study First Received: November 30, 2007
Last Updated: June 28, 2012
Health Authority: Turkey: Ministry of Health Drug and Pharmaceutical Department

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal 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 23, 2013