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OpenTrials
Completed

NCT Number: NCT00567385

Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

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

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Key information

Conditions

Growth Hormone Disorder Growth Hormone Deficiency in Children

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Altunizade-Istanbul, 34662, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Somatropin

Drug

Primary outcomes

  1. Assessment of acceptance

    Time frame: after 12 weeks of treatment

Secondary outcomes

  1. Safety

  2. Adverse Events (AE)

  3. Compliance

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Open, Multi-centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin® SimpleXx® in Children With GH Deficiency

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Dec 4, 2007
Registry last updated
Feb 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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