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

NCT01327924 | Completed

• 2 other identifiers: GH-3870U1111-1119-8619
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Usability of growth hormone injection device assessed by a quantitative scale

  after 3 months of growth hormone treatment

Secondary Outcomes (2)

• Number of adverse events

  from 0 - 3 months of growth hormone treatment

• Number of technical complaints

  from 0 to 3 months of growth hormone treatment

Study Arms (1)

Norditropin NordiFlex® users

Drug: Norditropin NordiFlex®

Interventions

Norditropin NordiFlex® DRUG

Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.

Norditropin NordiFlex® users

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Paris La Défense Cedex, 92932, France

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Genetic Diseases, Inborn; Turner Syndrome; Renal Insufficiency, Chronic

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Dysgenesis; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Sex Chromosome Disorders of Sex Development; Male Urogenital Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Sex Chromosome Disorders; Chromosome Disorders; Gonadal Disorders; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2011
• First Posted: April 4, 2011
• Study Start: April 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 24, 2014

Record last verified: 2014-06

Locations

FR (1)