This trial is active, not recruiting.

Conditions foetal growth problem, small for gestational age
Treatment somatropin
Sponsor Novo Nordisk A/S
Start date November 2009
End date October 2018
Trial size 360 participants
Trial identifier NCT01110928, GH-3812, JapicCTI-101123, U1111-1114-6280


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
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.

Primary Outcomes

Number and type of suspected serious adverse drug reactions (SADRs) during the study period
time frame: evaluated binannually for 9 years

Secondary Outcomes

Number of glucose intolerance events during the study period
time frame: evaluated biannually for 9 years
Adult height
time frame: 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

Male or female participants of any age.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.