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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01110928
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : January 11, 2019
Information provided by (Responsible Party):
Novo Nordisk A/S

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
Foetal Growth Problem Small for Gestational Age Drug: somatropin

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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 : November 26, 2009
Actual Primary Completion Date : November 12, 2018
Actual Study Completion Date : November 12, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dwarfism

Group/Cohort 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.

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

Secondary Outcome Measures :
  1. Number of glucose intolerance events during the study period [ Time Frame: evaluated biannually for 9 years ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SGA short stature that are still growing, who will either receive Norditropin® (somatropin) treatment or completed the GHLIQUID-1517 trial.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01110928

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Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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

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Responsible Party: Novo Nordisk A/S Identifier: NCT01110928     History of Changes
Other Study ID Numbers: GH-3812
U1111-1114-6280 ( Other Identifier: WHO )
JapicCTI-101123 ( Registry Identifier: JAPIC )
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases