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

Small for Gestational Age Clinical Trial

Official title:

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate on Long-term Safety and Efficacy of Norditropin® Formulation in Patients With SGA Short Stature Without Closure of Epiphyseal Discs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01110928
• Other study ID #: GH-3812
• Secondary ID: U1111-1114-6280J
• Status: Completed
• Start date: November 26, 2009
• Est. completion date: November 12, 2018

Study information

• Verified date: January 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is conducted in Japan. The aim of this observational study is to collect information about the safety and efficacy of Norditropin® in the long-term treatment of patients with a SGA (small for gestational age) short stature where the growth plate in the long bones (epiphyseal disc) is not closed. An extension to the GHLIQUID-1517 trial (NCT00184717).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 227
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participation in the GHLIQUID-1517 trial

• Patients with SGA (small for gestational age) short stature that are still growing

Exclusion Criteria:

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

• Diabetes Mellitus

• Patients with malignant tumor(s)

• Pregnant or likely to get pregnant

Related Conditions & MeSH terms

• Dwarfism
• Foetal Growth Problem
• Small for Gestational Age

Intervention

Drug:
• somatropin
Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.

Locations

Country	Name	City	State
Japan	Novo Nordisk Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Toshiaki Tanaka et al, The effect of growth hormone treatment on age and height at puberty onset in short Japanese children born small for gestational age: interim analysis of Norditropin post-marketing study; Japan, Journal of Japanese Association for Human Auxology; 2017: Vol 23 No. 2 : p59

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of suspected serious adverse drug reactions (SADRs) during the study period		evaluated binannually for 9 years
Secondary	Number of glucose intolerance events during the study period		evaluated biannually for 9 years
Secondary	Adult height		Fulfilment will be evaluated once a year. Height when closure of ephiphyseal discs exists or when accomplished adult height is confirmed by physician

External Links

•   Clinical Trials at Novo Nordisk