Special Survey for Long Term Application

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: June 26, 2012
Last verified: January 2012
  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) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective [ Designated as safety issue: No ]

Enrollment: 395
Study Start Date: May 1997
Study Completion Date: March 2007
Primary Completion Date: March 2006 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01516229

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Masayuki Senda Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, 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: June 26, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Achondroplasia
Genetic Diseases, Inborn
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Osteochondrodysplasias

ClinicalTrials.gov processed this record on April 17, 2014