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NCT01516229 Clinical Trial

Special Survey for Long Term Application

Achondroplasia Clinical Trial

Official title:
Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01516229
Other study ID # GH-1941
Secondary ID
Status Completed
Phase N/A
First received January 19, 2012
Last updated February 23, 2017
Start date May 1, 1997
Est. completion date March 31, 2007

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 395
Est. completion date March 31, 2007
Est. primary completion date March 31, 2007
Accepts healthy volunteers No
Gender All
Age group 1 Year to 15 Years
Eligibility Inclusion Criteria:

- Achondroplasia without epiphyseal line closure

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• somatropin
Prescription of somatropin at the discretion of the physician

Locations
Country Name City State
Japan Novo Nordisk Investigational Site Tokyo
Japan Novo Nordisk Investigational Site Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of adverse drug reactions (ADRs)
Secondary Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective
See also
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Completed NCT05659719 - A Study to Learn About Recifercept in Patients With Achondroplasia
Active, not recruiting NCT04554940 - A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia Phase 2
Completed NCT01435629 - A Survey Collecting Data on Adult Height in Patients With Achondroplasia Treated With Somatropin N/A
Enrolling by invitation NCT06164951 - A Study to Evaluate the Efficacy and Safety of Infigratinib in Children and Adolescents With Achondroplasia Phase 3
Completed NCT03583697 - A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia Phase 2
Completed NCT03872531 - Lifetime Impact Study for Achondroplasia
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Recruiting NCT05603936 - Adaption and Testing of the Quality of Life in Short Stature Youth (QoLISSY) Questionnaire for Parents With Children From 0-4
Completed NCT03780153 - The Norwegian Adult Achondroplasia Study
Active, not recruiting NCT04085523 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of TransCon CNP Administered Once Weekly in Prepubertal Children With Achondroplasia Phase 2
Enrolling by invitation NCT05929807 - A Clinical Trial to Investigate Long-term Safety, Tolerability, and Efficacy of Weekly Subcutaneous Doses With TransCon CNP in Children and Adolescents With Achondroplasia Phase 2/Phase 3
Completed NCT03875534 - A Multi-center, Longitudinal, Observational Study of Children With Achondroplasia
Terminated NCT03794609 - Observational Study Investigating Clinical & Anthropometric Characteristics of Children With Achondroplasia.
Active, not recruiting NCT03989947 - An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia Phase 2
Active, not recruiting NCT05246033 - A Dose Escalation Trial Evaluating Safety, Efficacy, and Pharmacokinetics of Multiple Subcutaneous Doses of TransCon CNP Administered Once Weekly in Children With Achondroplasia Phase 2
Active, not recruiting NCT02724228 - A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH) Phase 2

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