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Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks
Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation provides a higher concentration and thereby a smaller volume to be administered. ZomaJet Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin and into the subcutaneous tissue without the use of a needle. The mode of administration is referred to as "transjection". By use of ZomaJet Vision X, both transjection and reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet Vision X.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZOMACTON | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X |
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Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6, | Olomouc | 775 20 | Czechia | |||
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| ID | Term |
|---|---|
| D014424 | Turner Syndrome |
| ID | Term |
|---|---|
| D006059 | Gonadal Dysgenesis |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
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| Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159 |
| Prague |
| 100 81 |
| Czechia |
| Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a | Ústí nad Labem | 401 13 | Czechia |
| Centre d'Endocrinologie Pediatrique, 25 rue Boudet | Bordeaux | 33000 | France |
| Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert | Le Havre | 76083 | France |
| Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057 | Amsterdam | 10007 MB | Netherlands |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D058533 | Sex Chromosome Disorders of Sex Development |
| D052801 | Male Urogenital Diseases |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025064 | Sex Chromosome Disorders |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |