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Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00567385
Recruitment Status : Completed
First Posted : December 4, 2007
Last Update Posted : February 28, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Drug: somatropin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 10, 2003
Actual Primary Completion Date : March 22, 2004
Actual Study Completion Date : March 22, 2004

Primary Outcome Measures :
  1. Assessment of acceptance [ Time Frame: after 12 weeks of treatment ]

Secondary Outcome Measures :
  1. Safety
  2. Adverse Events (AE)
  3. Compliance

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00567385

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Novo Nordisk Investigational Site
Altunizade-Istanbul, Turkey, 34662
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00567385     History of Changes
Other Study ID Numbers: GHLIQUID-1515
First Posted: December 4, 2007    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs