Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents - Full Text View

Purpose

This study is conducted in Europe. The aim of this study is to compare the easiness of use of Norditropin NordiFlex® device to the device previously used by patients or parents.

Condition	Intervention	Phase
Growth Hormone Disorder Growth Hormone Deficiency in Children Foetal Growth Problem Small for Gestational Age Genetic Disorder Turner Syndrome Chronic Kidney Disease Chronic Renal Insufficiency Delivery Systems	Drug: Norditropin NordiFlex®	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents

Resource links provided by NLM:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia persistent Müllerian duct syndrome pseudoachondroplasia tetrasomy 18p Turner syndrome

MedlinePlus related topics: Chronic Kidney Disease Kidney Failure Turner Syndrome

Drug Information available for: Somatropin

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Analysed for the ITT (intent-to-treat) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.
The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Analysed for the PP (per protocol) analysis set: The relative ease of use of the trial injection device compared to the device previously used was assessed using a quantitative scale, ranging from 0 to 10 with 0 = NordiFlex® is far less simple, 5 = equivalent simplicity and 10 = NordiFlex® is far more simple. The participants had to circle the number that represented their perception of the current state.

Secondary Outcome Measures:

Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Dose Modification [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.
Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Dose Modification [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Injection Easiness [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. Ordinal variables were used for the evaluation (very easy, easy, fairly easy, difficult and very difficult).
Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The overall simplicity of use was evaluated at every step of the injection preparation (dose selection, injection and dose modification) and using the time spent in the preparation of the injection. This was evaluated using time intervals: below 5 minutes, 5-10 minutes, 10-20 minutes.
Ease of Learning Assessed by the Physician or the Nurse: Ease of Training [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Ease of learning was evaluated using ordinal variables (very easy, easy and difficult).
Ease of Learning Assessed by the Physician or the Nurse: Time Learning [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. Time to learning was assessed using time intervals: 6-10 minutes, 11-15 minutes, 16-30 minutes and 31 minutes to 1 hour.
Ease of Learning Assessed by the Physician or the Nurse: Added Values of the Products [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The person in charge, physician or nurse, of giving all the instruction of use to patients or parents assessed the ease of learning of the Nordiflex® device. An added value of device was evaluated by the physician or the nurse using categorical variables.
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.
Patient Autonomy: Percentage of Patients Performing Operations for Treatment Injection [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The patient autonomy was evaluated using percentage of participants who performed all the operations of the treatment administration including dose selection, dose modification in case of error and injection.
Patient Preference: Percentage of Participants Preferring System for Continuation of Growth Hormone Treatment [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
The patient preference was evaluated using the percentage of participants preferring the new system, old system or none of them for their growth hormone therapy.
Number of Participants Reporting Adverse Events, Medical Events of Special Interest (MESI) and Technical Problems With Devices Used in Trial [ Time Frame: Weeks 0 - 6 ] [ Designated as safety issue: No ]

Enrollment:	103
Study Start Date:	November 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Norditropin NordiFlex® Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).	Drug: Norditropin NordiFlex® Daily administration by a 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:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children who can receive Norditropin® (somatropin) treatment according to the product labelling
Treated with growth hormone for at least one year

Exclusion Criteria:

Contraindications to Norditropin® growth hormone therapy
Known or suspected hypersensitivity to somatropin or related products
The receipt of any investigational medicinal product within 3 months prior to study start
Life threatening disease, for example cancer
Pregnancy or the intention of becoming pregnant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245374

Locations

France

Paris La défense cedex, France, 92932

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Delphine Jaquet

Novo Nordisk Pharmaceutique S.A.S

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT01245374 History of Changes
Other Study ID Numbers:	GH-3826, U1111-1117-1194, 2009-017387-16
Study First Received:	November 19, 2010
Results First Received:	April 18, 2012
Last Updated:	October 19, 2012
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 June 18, 2013