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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004849-28 |
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This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone deficiency in children. The children will be treated for 1 year. Half of the patients will be treated with Genotropin and half with Zomacton. During this time they will be dosed every day by themselves or their parents at home in the evening. There will be 138 patients in the trial from age 3 to age 11. The patients cannot have been treated before with growth hormone and the patients must have a proven growth hormone deficiency, this will be shown by a specific test that will be performed before the trial in the local clinic and once during the trial. During the time of the treatment the patients will come to visit the clinic every 3 months. At these visits their heights will be measured, blood samples will be taken, physical examinations will be performed and questions about their health will be asked. At 2 times in the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial the patients will stop the treatment and continue on one of the marketed products available to treat growth hormone deficiency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Genotropin | Drug |
| ||
| Zomacton |
| Measure | Description | Time Frame |
|---|---|---|
| Height Velocity | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Height SDS | 12 months | |
| Height velocity SDS | 12 months | |
| Change in IGF-1 and IGFBP-3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Development Support | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweiss University, 1st dept of paediatrics | Budapest | Hungary | ||||
| Szent Janos Kh Budai |
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|
| 12 months |
| BA (Bone Age) | 12 months |
| Anti-hGH AB | 12 months |
| AE and tolerability | 12 months |
| CS Changes in safety lab, physical examination and vital signs | 12 months |
| Budapest |
| Hungary |
| Petz Country Teaching Hospital | Győr | Hungary |
| University of Szeged | Szeged | Hungary |
| Markusovszkty Teaching Hospital | Szombathely | Hungary |
| Associates in Clinical Endocrinology Education and Research (ACEER) | Chennai | India |
| Apollo Hospitals | Hyderabad | India |
| TOTALL Diabetes Hormone Institute | Indore | India |
| KEM Hospital | Mumbai | India |
| Prince Aly Khan Hospital | Mumbai | India |
| Endocare Clinic | Nashik | India |
| Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital | Pune | India |
| Health & Research Centre | Trivandrum | India |
| Haemek Medical Center | Afula | Israel |
| Soroka University Medical Center | Beersheba | Israel |
| Western Galilee Medical Center | Nahariya | Israel |
| Schneider Children's Medical Center of Israel | Petah Tikva | Israel |
| Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center | Ramat Gan | Israel |
| Kaplan Medical Center | Rehovot | Israel |
| Dana Children's Hospital - Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
| Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy | Bydgoszcz | Poland |
| Uniwersyteckie Centrum Kliniczne, Gdańsk | Gdansk | Poland |
| Uniwersytecki Szpital Dziecięcy w Krakowie | Krakow | Poland |
| SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin | Szczecin | Poland |
| Societatea Civila Medicala "Dr. Paveliu" | Bucharest | Romania |
| Spitalul Clinic Municipal "Filantropia" | Craiova | Romania |
| Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" | Iași | Romania |
| Spitalul Clinic Judetean Mures | Târgu Mureş | Romania |
| Paediatric Endocrinology/Medicali's SRL | Timișoara | Romania |
| Spitalul Clinic pentru Copii Louis Turcanu | Timișoara | Romania |
| State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV | Kazan' | Russia |
| Federal State Institution | Moscow | Russia |
| Russian Medical Academy of Post-graduate Education | Moscow | Russia |
| Saint-Petersburg State Health Care Institution | Saint Petersburg | Russia |
| State Educational Institution for Higher Professional Education | Saratov | Russia |
| State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV | Tomsk | Russia |
| Donetsk Regional Clinical Children's Hospital | Donetsk | Ukraine |
| Ivano-Frankivsk Regional Children Clinical Hospital | Ivano-Frankivsk | Ukraine |
| Kharkiv Regional Clinical Children's Hospital | Kharkiv | Ukraine |
| Institute of Endocrinology and Metabolism | Kiev | Ukraine |
| Ukrainian Children's Specialized Clinical Hospital | Kiev | Ukraine |
| Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital) | Odesa | Ukraine |
| Zaporizhzhya Regional Paediatric Hospital | Zaporizhya | Ukraine |
| ID | Term |
|---|---|
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System 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 |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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