Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01563926
First received: March 23, 2012
Last updated: June 28, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Hormone Disorder Growth Hormone Deficiency in Children Genetic Disorder Turner Syndrome |
Drug: somatropin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open, Multi-Centre Trial Evaluating Acceptance of the New Liquid Growth Hormone Formulation - Norditropin Simplexx™ in Children With GH Deficiency |
Resource links provided by NLM:
Genetics Home Reference related topics:
combined pituitary hormone deficiency
isolated growth hormone deficiency
metatropic dysplasia
persistent Müllerian duct syndrome
pseudoachondroplasia
tetrasomy 18p
Turner syndrome
MedlinePlus related topics:
Turner Syndrome
Drug Information available for:
Somatropin
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Patient acceptance of the new liquid growth hormone formulation [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Number of Adverse Events (AE) [ Designated as safety issue: No ]
- Number of Serious Adverse Events (SAE) [ Designated as safety issue: No ]
| Enrollment: | 168 |
| Study Start Date: | October 2000 |
| Study Completion Date: | October 2002 |
| Primary Completion Date: | October 2002 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Somatropin |
Drug: somatropin
Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01563926 History of Changes |
| Other Study ID Numbers: | GHLIQUID-1315 |
| Study First Received: | March 23, 2012 |
| Last Updated: | June 28, 2012 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
|
Dwarfism, Pituitary Genetic Diseases, Inborn Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Endocrine System Diseases Dwarfism Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Bone Diseases, Endocrine Hypopituitarism Pituitary Diseases Hypothalamic Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Gonadal Disorders Ovarian Diseases Adnexal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013