NCT01435629

Brief Summary

This study is conducted in Japan. The aim of the study is to evaluate the efficacy of somatropin (Norditropin®) on adult height (cm) in patients with achondroplasia / hypochondroplasia enrolled in the GH-1941 study (NCT01516229).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

September 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 22, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 4, 2015

Completed
Last Updated

May 5, 2017

Status Verified

May 1, 2017

Enrollment Period

3 years

First QC Date

September 14, 2011

Last Update Submit

May 4, 2017

Conditions

Genetic DisorderAchondroplasia

Outcome Measures

Primary Outcomes (1)

  • To collect change data of adult height (cm) of patients treated with Norditropin® and evaluate the long-term efficacy

    At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

Secondary Outcomes (1)

  • To monitor the patients to see if they undergo lower limb lengthening

    At year 1, 2, 3, 4, and 5 after the patient has reached adult height or is 18 of age

Study Arms (1)

Norditropin®

Drug: somatropin

Interventions

somatropinDRUG

Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.

Norditropin®

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients enrolled in the GH-1941 study (NCT01516229) expected to achieve the adult height by 2015 and available for follow-up by the investigator

You may qualify if:

  • Patients who were enrolled in the GH-1941 study (1997 to 2006) and expected to theoretically reach the adult height within the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Tokyo, 1000005, 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
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 16, 2011

Study Start

November 22, 2012

Primary Completion

December 4, 2015

Study Completion

December 4, 2015

Last Updated

May 5, 2017

Record last verified: 2017-05

Locations

JP(1)