Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00567385
• Date of registration: 30/11/2007
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
• Scientific title: An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency
• Date of first enrolment: March 10, 2003
• Target sample size: 176
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00567385
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Global Clinical Registry (GCR, 1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion criteria

Inclusion Criteria:

- Growth failure due to growth hormone insufficiency (GHD)

- Turner syndrome: established diagnosis according to sex chromosome analysis, or

- Growth retardation in children with chronic renal disorders

Exclusion Criteria:

- Pregnancy

- Breast feeding women

- Suspected or know allergy to trial product

- Participating in any other trial involving other investigational products within the
last 3 months

- Previous participation in the trial

- Other daily injection therapy (non-growth hormone, e.g insulin-therapy)



Age minimum: 3 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency in Children

Growth Hormone Disorder

Intervention(s)

Drug: somatropin

Primary Outcome(s)

Assessment of acceptance [Time Frame: after 12 weeks of treatment]

Secondary Outcome(s)

Safety

Adverse Events (AE)

Compliance

Secondary ID(s)

GHLIQUID-1515

Source(s) of Monetary Support

Please refer to primary and secondary sponsors