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Norditropin NordiFlex® Device Compared to the Device Previously Used by Patients or Parents | Clinical Trials | Clareo Health

COMPLETEDPHASE4

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

Assessment of the Ease of Use of Norditropin NordiFlex® Relative to the One of the Device Previously Used by Patients or Parents

NCT01245374•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

6 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Novo Nordisk Investigational Site

Paris La Défense Cedex, France

Key Dates

Start Date

November 1, 2010

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

February 27, 2017

Enrollment

103

ACTUAL participants

Conditions

Growth Hormone DisorderGrowth Hormone Deficiency in ChildrenFoetal Growth ProblemSmall for Gestational AgeGenetic DisorderTurner SyndromeChronic Kidney DiseaseChronic Renal InsufficiencyDelivery Systems

Interventions

Norditropin NordiFlex®

DEVICE

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Growth Hormone Deficiency in Children

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COMPLETEDPHASE3

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

NCT04970654

Growth Hormone Deficiency in Children

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COMPLETEDPHASE1

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Observational Study of the Safety and Efficacy of Norditropin® in Patients With SGA (Small for Gestational Age) Short Stature That Are Still Growing