Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents

NCT01245374 | Completed Phase 4 Results

• 3 other identifiers: GH-3826U1111-1117-11942009-017387-16
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

  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.

  Week 6

• The Relative Ease of Use of NordiFlex® Compared to the Device Previously Used

  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.

  Week 6

Secondary Outcomes (15)

• Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

  Week 0

• Percentage of Participants Evaluating Simplicity of Use: Dose Modification

  Week 0

• Percentage of Participants Evaluating Simplicity of Use: Injection Easiness

  Week 0

• Percentage of Participants Evaluating Simplicity of Use: Time Spent in the Preparation of the Injection

  Week 0

• Percentage of Participants Evaluating Simplicity of Use: Dose Selection Easiness

  Week 6

Study Arms (1)

Nordiflex Norditropin®

EXPERIMENTAL

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)

Device: Norditropin NordiFlex®

Interventions

Norditropin NordiFlex® DEVICE

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

Nordiflex Norditropin®

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Location

Related Publications (1)

• Tauber M, Jaquet D, Jesuran-Perelroizen M, Petrus M, Bertrand AM, Coutant R; NordiFlex(R) French Study Group. User assessment of Norditropin NordiFlex((R)), a new prefilled growth hormone pen: a Phase IV multicenter prospective study. Patient Prefer Adherence. 2013 May 24;7:455-62. doi: 10.2147/PPA.S43460. Print 2013.

  PMID: 23737664 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

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

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

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: November 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: February 27, 2017
• Results First Posted: June 25, 2012

Record last verified: 2017-01

Locations

FR (1)