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Special Survey for Long Term Application

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01516229
First received: January 19, 2012
Last updated: June 26, 2012
Last verified: January 2012
History of Changes
  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:

Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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
Investigators
Study Director: Masayuki Senda Novo Nordisk Pharma Ltd.
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

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 May 23, 2013