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Evaluating Acceptance of New 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.
 
ClinicalTrials.gov Identifier: NCT01563926
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.

Condition or disease Intervention/treatment Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Genetic Disorder Turner Syndrome Drug: somatropin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 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 : October 23, 2000
Actual Primary Completion Date : October 10, 2002
Actual Study Completion Date : October 10, 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Somatropin Drug: somatropin
Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)


Outcome Measures
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Primary Outcome Measures :
  1. Patient acceptance of the new liquid growth hormone formulation

Secondary Outcome Measures :
  1. Number of Adverse Events (AE)
  2. Number of Serious Adverse Events (SAE)

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written Informed Consent by patient and/or guardian/parents
  • Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
  • Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
  • Patients on growth hormone therapy for at least 6 weeks before entering the trial

Exclusion Criteria:

  • Pregnancy or breast feeding women
  • Suspected or known allergy to trial product
  • Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
  • Participating in any other trial involving other investigational products within the last 3 months
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01563926


Locations
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Israel
Novo Nordisk Investigational Site
Afula, Israel, 18101
Novo Nordisk Investigational Site
Beer Sheva, Israel, 84101
Novo Nordisk Investigational Site
Jerusalem, Israel, 91240
Novo Nordisk Investigational Site
Petah Tikva, Israel, 49202
Novo Nordisk Investigational Site
Rehovot, Israel, 76100
Novo Nordisk Investigational Site
Tel - Aviv, Israel, 64293
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563926    
Other Study ID Numbers: GHLIQUID-1315
First Posted: March 27, 2012    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Turner Syndrome
Gonadal Dysgenesis
Genetic Diseases, Inborn
Disease
Pathologic Processes
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
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Gonadal Disorders