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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01110928
• Collaborator: (none)
• Enrollment: 227
• Location: 1
• Actual Duration (Months): 107.5
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Foetal Growth Problem; Small for Gestational Age	Drug: somatropin

Study Design

• Study Type: Observational
• Actual Enrollment: 227 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Nov 26, 2009
• Actual Primary Completion Date: Nov 12, 2018
• Actual Study Completion Date: Nov 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Norditropin®	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.

Outcome Measures

Primary Outcome Measures

1. Number and type of suspected serious adverse drug reactions (SADRs) during the study period [evaluated binannually for 9 years]

Secondary Outcome Measures

1. Number of glucose intolerance events during the study period [evaluated biannually for 9 years]

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Tokyo		Japan	1000005

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

• 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

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01110928
• Other Study ID Numbers: GH-3812; U1111-1114-6280; JapicCTI-101123
• First Posted: Apr 27, 2010
• Last Update Posted: Jan 11, 2019
• Last Verified: Jan 1, 2019

• Additional relevant MeSH terms: Dwarfism

Study Results

No Results Posted as of Jan 11, 2019