Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency
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ClinicalTrials.gov Identifier: NCT01563926 |
Recruitment Status :
Completed
First Posted : March 27, 2012
Last Update Posted : February 27, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Growth Hormone Disorder Growth Hormone Deficiency in Children Genetic Disorder Turner Syndrome | Drug: somatropin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 168 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Actual Study Start Date : | October 23, 2000 |
Actual Primary Completion Date : | October 10, 2002 |
Actual Study Completion Date : | October 10, 2002 |

Arm | Intervention/treatment |
---|---|
Experimental: Somatropin |
Drug: somatropin
Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin) |
- Patient acceptance of the new liquid growth hormone formulation
- Number of Adverse Events (AE)
- Number of Serious Adverse Events (SAE)

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563926
Israel | |
Novo Nordisk Investigational Site | |
Afula, Israel, 18101 | |
Novo Nordisk Investigational Site | |
Beer Sheva, Israel, 84101 | |
Novo Nordisk Investigational Site | |
Jerusalem, Israel, 91240 | |
Novo Nordisk Investigational Site | |
Petah Tikva, Israel, 49202 | |
Novo Nordisk Investigational Site | |
Rehovot, Israel, 76100 | |
Novo Nordisk Investigational Site | |
Tel - Aviv, Israel, 64293 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01563926 |
Other Study ID Numbers: |
GHLIQUID-1315 |
First Posted: | March 27, 2012 Key Record Dates |
Last Update Posted: | February 27, 2017 |
Last Verified: | February 2017 |
Dwarfism, Pituitary Turner Syndrome Gonadal Dysgenesis Genetic Diseases, Inborn Disease Pathologic Processes 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 |