Brief Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.

Trial Health

On Track

Trial Health Score

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

Enrollment

168

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Oct 2000

Geographic Reach

1 country

6 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

2 years study duration

Study Start

First participant enrolled

October 23, 2000

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2002

Completed

9.5 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed

Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

March 23, 2012

Last Update Submit

February 23, 2017

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children Genetic Disorder Turner Syndrome

Outcome Measures

Primary Outcomes (1)

Patient acceptance of the new liquid growth hormone formulation

Secondary Outcomes (2)

Number of Adverse Events (AE)
Number of Serious Adverse Events (SAE)

Study Arms (1)

Somatropin

EXPERIMENTAL

Drug: somatropin

Interventions

somatropinDRUG

Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)

Somatropin

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Written Informed Consent by patient and/or guardian/parents
Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
Patients on growth hormone therapy for at least 6 weeks before entering the trial

You may not qualify if:

Pregnancy or breast feeding women
Suspected or known allergy to trial product
Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
Participating in any other trial involving other investigational products within the last 3 months

Contact the study team to confirm eligibility.