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

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

Sponsors

Lead sponsor: Novo Nordisk A/S

Source Novo Nordisk A/S
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.

Overall Status Completed
Start Date October 23, 2000
Completion Date October 10, 2002
Primary Completion Date October 10, 2002
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Patient acceptance of the new liquid growth hormone formulation
Secondary Outcome
Measure Time Frame
Number of Adverse Events (AE)
Number of Serious Adverse Events (SAE)
Enrollment 168
Condition
Intervention

Intervention type: Drug

Intervention name: somatropin

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

Arm group label: Somatropin

Eligibility

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Global Clinical Registry (GCR, 1452) Study Director Novo Nordisk A/S
Location
facility
Novo Nordisk Investigational Site | Afula, 18101, Israel
Novo Nordisk Investigational Site | Beer Sheva, 84101, Israel
Novo Nordisk Investigational Site | Jerusalem, 91240, Israel
Novo Nordisk Investigational Site | Petah Tikva, 49202, Israel
Novo Nordisk Investigational Site | Rehovot, 76100, Israel
Novo Nordisk Investigational Site | Tel - Aviv, 64293, Israel
Location Countries

Israel

Verification Date

February 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Somatropin

Arm group type: Experimental

Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov