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Special Survey for Long Term Application

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: January 19, 2012
Last updated: February 23, 2017
Last verified: February 2017
This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions.

Condition Intervention
Genetic Disorder
Drug: somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Incidence of adverse drug reactions (ADRs)

Secondary Outcome Measures:
  • Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective

Enrollment: 395
Actual Study Start Date: May 1, 1997
Study Completion Date: March 31, 2007
Primary Completion Date: March 31, 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Somatropin Drug: somatropin
Prescription of somatropin at the discretion of the physician


Ages Eligible for Study:   1 Year to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients being treated with somatropin for achondroplasia without epiphyseal line closure

Inclusion Criteria:

  • Achondroplasia without epiphyseal line closure
  Contacts and Locations
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Please refer to this study by its identifier: NCT01516229

Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Novo Nordisk Investigational Site
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01516229     History of Changes
Other Study ID Numbers: GH-1941
Study First Received: January 19, 2012
Last Updated: February 23, 2017

Additional relevant MeSH terms:
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn processed this record on May 22, 2017