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Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563926
First received: March 23, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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 Intervention Phase
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Genetic Disorder
Turner Syndrome
Drug: somatropin
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy 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:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Patient acceptance of the new liquid growth hormone formulation [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Adverse Events (AE) [ Designated as safety issue: No ]
  • Number of Serious Adverse Events (SAE) [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: October 2000
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Somatropin Drug: somatropin
Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563926

Locations
Israel
Beer Sheva, Israel, 84101
Petah Tikva, Israel, 49202
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Shirlee Sagiv Novo Nordisk Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563926     History of Changes
Other Study ID Numbers: GHLIQUID-1315
Study First Received: March 23, 2012
Last Updated: June 28, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Disease
Dwarfism, Pituitary
Endocrine System Diseases
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Turner Syndrome
Adnexal Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Central Nervous System Diseases
Chromosome Disorders
Congenital Abnormalities
Disorders of Sex Development
Dwarfism
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Ovarian Diseases
Pathologic Processes
Pituitary Diseases

ClinicalTrials.gov processed this record on November 20, 2014