Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01500486
First received: December 22, 2011
Last updated: June 26, 2012
Last verified: March 2012
  Purpose

This study is conducted in Europe. The aim of this study is to evaluate ease of injection of growth hormone in patients using Norditropin NordiFlex® with NordiFlex PenMate™. Convenience and tolerability of NordiFlex PenMate™ - an automatic injection and a needle hiding device - is also evaluated.


Condition Intervention
Growth Hormone Disorder
Growth Hormone Deficiency in Children
Delivery Systems
Device: NordiFlex PenMate™

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study to Assess Ease of Use, Acceptability and Preference of Norditropin NordiFlex® With NordiFlex PenMate™ in Subjects on Prescribed Growth Hormone Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The proportion of subjects that find growth hormone injection using Norditropin Nordiflex® with NordiFlex PenMate™ very easy or easy as assessed by patient/parent questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
  • Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Compliance to treatment as assessed by patient/parent diary [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Evaluation of tolerability, when using Norditropin Nordiflex® with NordiFlex PenMate™, by collecting Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs) and clinical technical complaints [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: January 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PenMate device Device: NordiFlex PenMate™
Subjects whom will be offered growth hormone (Norditropin NordiFlex®) on prescription as part of normal clinical practice will be asked to evaluate the NordiFlex PenMate™ device.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects from secondary care physicians who prescribe growth hormone will be included in the study. Children who are available for Norditropin® treatment in accordance with the labelling will be included in the study: Newly-diagnosed subjects who have never received growth hormone therapy before and subjects in whom physician identifies a need for switch to another growth hormone preparation

Criteria

Inclusion Criteria:

  • After the physician decision has been made to use Norditropin Nordiflex® growth hormone therapy in accordance with the locally approved labelling, any subject is eligible for the study, including newly diagnosed subjects who have never received growth hormone therapy before and subjects who were treated with the other growth hormone products (with exclusion of patients who received previously Norditropin Nordiflex®) and need to be switched to a new product. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

  • Contraindications to Norditropin® growth hormone therapy
  • Subjects who have received Norditropin NordiFlex® prior to this study
  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: NCT01500486

Locations
Germany
Mainz, Germany, 55127
Netherlands
Alphen a/d Rijn, Netherlands
Sweden
Malmö, Sweden, SE-202 15
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Viatcheslav Rakov, MD Novo Nordisk Health Care AG
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01500486     History of Changes
Other Study ID Numbers: GH-3717
Study First Received: December 22, 2011
Last Updated: June 26, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Dutch Health Care Inspectorate
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Dwarfism, Pituitary
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

ClinicalTrials.gov processed this record on August 28, 2014