Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT01604161
• Date of registration: 21/05/2012
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Non-interventional Study of Patients Using Norditropin® for Growth Hormone Deficiency or Turner Syndrome NordiPAD
• Scientific title: A Multicentre, Open Label, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Child Patients With GHD or Turner Short Stature Without Closure of Epiphyseal Discs.
• Date of first enrolment: May 2005
• Target sample size: 2016
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01604161
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Japan

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Growth hormone deficiency or short stature due to Turner Syndrome where the
epiphyseal discs are not closed

Exclusion Criteria:

- Diabetic

- Patients with malignant tumors

- Women who are either pregnant or likely to be pregnant

- Known or suspected allergy to study product(s) or related products



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency in Children

Growth Hormone Disorder

Genetic Disorder

Turner Syndrome

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Change from baseline in height [Time Frame: Week 0, Month 36, final height is reached]

Incidence of adverse reactions (ADRs) [Time Frame: 36 months, accumulation of study period]

Secondary ID(s)

GH-3910

Source(s) of Monetary Support

Please refer to primary and secondary sponsors