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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01110928
First received: April 19, 2010
Last updated: April 8, 2014
Last verified: February 2014
  Purpose

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 Intervention
Foetal Growth Problem
Small for Gestational Age
Drug: somatropin

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Number and type of suspected serious adverse drug reactions (SADRs) during the study period [ Time Frame: evaluated binannually for 9 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of glucose intolerance events during the study period [ Time Frame: evaluated biannually for 9 years ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: November 2009
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110928

Locations
Japan
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Tsutomu Katakura Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01110928     History of Changes
Other Study ID Numbers: GH-3812, U1111-1114-6280, JapicCTI-101123
Study First Received: April 19, 2010
Last Updated: April 8, 2014
Health Authority: Japan: Pharmaceuticals and medical devices agency (PMDA)

Additional relevant MeSH terms:
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 27, 2014