Clinical trial NCT01500486: Observational Study of Norditropin NordiFlex® With NordiFlex PenMate™
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Growth Hormone Disorder
Growth Hormone Deficiency in Children
Delivery Systems
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-28
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Week 12
Secondary outcomes:
measure: Ease of teaching how to use Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by nurse questionnaires
timeFrame: Week 0
measure: Patient/parent overall acceptance of Norditropin Nordiflex® with NordiFlex PenMate™ as assessed by questionnaire
timeFrame: Week 12
measure: Compliance to treatment as assessed by patient/parent diary
timeFrame: Week 12
measure: 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
timeFrame: Week 12
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Novo Nordisk Investigational Site
city: Alphen a/d Rijn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: