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Special Survey for Long Term Application

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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
Achondroplasia
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

  Eligibility

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
Criteria

Inclusion Criteria:

  • Achondroplasia without epiphyseal line closure
  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: NCT01516229

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

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov 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:
Achondroplasia
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on March 29, 2017