NCT01516229

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1997

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1997

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2007

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

9.9 years

First QC Date

January 19, 2012

Last Update Submit

February 23, 2017

Conditions

Genetic DisorderAchondroplasia

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reactions (ADRs)

Secondary Outcomes (1)

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

Study Arms (1)

Somatropin

Drug: somatropin

Interventions

somatropinDRUG

Prescription of somatropin at the discretion of the physician

Somatropin

Eligibility Criteria

Age1 Year - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients being treated with somatropin for achondroplasia without epiphyseal line closure

You may qualify if:

  • Achondroplasia without epiphyseal line closure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Location

Novo Nordisk Investigational Site

Tokyo, 103, Japan

Location

Related Links

MeSH Terms

Conditions

Genetic Diseases, InbornAchondroplasia

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesDwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesOsteochondrodysplasias

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2012

First Posted

January 24, 2012

Study Start

May 1, 1997

Primary Completion

March 31, 2007

Study Completion

March 31, 2007

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations

JP(2)