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NCT01563926 Clinical Trial

Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

Turner Syndrome Clinical Trial

Official title:
An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01563926
Other study ID # GHLIQUID-1315
Secondary ID
Status Completed
Phase Phase 3
First received March 23, 2012
Last updated February 23, 2017
Start date October 23, 2000
Est. completion date October 10, 2002

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

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 168
Est. completion date October 10, 2002
Est. primary completion date October 10, 2002
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Israel Novo Nordisk Investigational Site Afula
Israel Novo Nordisk Investigational Site Beer Sheva
Israel Novo Nordisk Investigational Site Jerusalem
Israel Novo Nordisk Investigational Site Petah Tikva
Israel Novo Nordisk Investigational Site Rehovot
Israel Novo Nordisk Investigational Site Tel - Aviv

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

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient acceptance of the new liquid growth hormone formulation
Secondary Number of Adverse Events (AE)
Secondary Number of Serious Adverse Events (SAE)
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Completed NCT00471731 - Dry Eye in Women With Turner Syndrome and Women With Premature Ovarian Failure N/A
Completed NCT00256126 - Predictive Markers in Growth Hormone Deficiency (GHD) and Turner Syndrome (TS) Children Treated With SAIZEN® Phase 4
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