Usability and Tolerability of the Norditropin NordiFlex® Injection Device in Children Never Previously Treated With Growth Hormone

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01327924
First received: March 31, 2011
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

This study is conducted in Europe. The purpose of this study is to assess the impact on daily life for children new to using a growth hormone injection device.


Condition Intervention
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Genetic Disorder
Turner Syndrome
Foetal Growth Problem
Small for Gestational Age
Chronic Kidney Disease
Chronic Renal Insufficiency
Delivery Systems
Drug: Norditropin NordiFlex®

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ease of Use and Tolerability of Norditropin NordiFlex® in Growth Hormone naïve Children: Impact on Daily Life

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Usability of growth hormone injection device assessed by a quantitative scale [ Time Frame: after 3 months of growth hormone treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of adverse events [ Time Frame: from 0 - 3 months of growth hormone treatment ] [ Designated as safety issue: No ]
  • Number of technical complaints [ Time Frame: from 0 to 3 months of growth hormone treatment ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Norditropin NordiFlex® users Drug: Norditropin NordiFlex®
Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Growth hormone treatment naïve children for whom a prescription of Norditropin NordiFlex® is initiated according to the SPC (Summary of Product Characteristics)

Criteria

Inclusion Criteria:

  • Growth hormone (GH) treatment naïve subjects for whom it has been decided to initiate GH treatment prior to enrollment into the study
  • Subjects who receive Norditropin NordiFlex® according to the SPC

Exclusion Criteria:

  • Known or suspected allergy to study product(s) or related products
  • Child and/or parent unable to give consent or fill out the questionnaires
  • The receipt of any investigational medicinal product within 3 months prior to this study
  • Suffer from a life-threatening disease
  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: NCT01327924

Locations
France
Paris La défense cedex, France, 92932
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01327924     History of Changes
Other Study ID Numbers: GH-3870, U1111-1119-8619
Study First Received: March 31, 2011
Last Updated: June 23, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dwarfism, Pituitary
Genetic Diseases, Inborn
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
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
Urologic Diseases
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 26, 2014