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| Sponsor: | Ferring Pharmaceuticals |
|---|---|
| Information provided by: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00884000 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Growth Hormone Deficiency |
Drug: Genotropin Drug: Zomacton |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency |
| Estimated Enrollment: | 138 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | May 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Active Comparator | Drug: Genotropin |
| 2: Experimental | Drug: Zomacton |
Eligibility| Ages Eligible for Study: | 3 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Clinical Development Support | DK0-Disclosure@ferring.com |
| Hungary | |
| Semmelweiss University, 1st dept of paediatrics | Recruiting |
| Budapest, Hungary | |
| Szent Janos Kh Budai | Recruiting |
| Budapest, Hungary | |
| Petz Country Teaching Hospital | Recruiting |
| Gyor, Hungary | |
| University of Szeged | Recruiting |
| Szeged, Hungary | |
| Markusovszkty Teaching Hospital | Recruiting |
| Szombathely, Hungary | |
| Israel | |
| Haemek Medical Center | Recruiting |
| Afula, Israel | |
| Soroka University Medical Center | Recruiting |
| Beer Sheva, Israel | |
| Schneider Children's Medical Center of Israel | Recruiting |
| Petach Tikva, Israel | |
| Edmond and Lily Safra Children's hospital - The Chaim Sheba Medical Center | Recruiting |
| Ramat Gan, Israel | |
| Kaplan Medical Center | Recruiting |
| Rehovot, Israel | |
| Dana Children's Hospital - Tel-Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel | |
| Poland | |
| Uniwersytecki Szpital Dziecięcy w Krakowie | Recruiting |
| Krakow, Poland | |
| Uniwersyteckie Centrum Kliniczne, Gdańsk | Recruiting |
| Gdansk, Poland | |
| Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy | Recruiting |
| Bydgoszcz, Poland | |
| SPSK nr.1 im. Prof. T. Sokołowskiego PAM Szczecin | Recruiting |
| Szczecin, Poland | |
| Romania | |
| Societatea Civila Medicala "Dr. Paveliu" | Recruiting |
| Bucuresti, Romania | |
| Spitalul Clinic Municipal "Filantropia" | Recruiting |
| Craiova, Romania | |
| Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" | Recruiting |
| Iasi, Romania | |
| Spitalul Clinic Judetean Mures | Recruiting |
| Targu Mures, Romania | |
| Spitalul Clinic pentru Copii Louis Turcanu | Recruiting |
| Timisoara, Romania | |
| Russian Federation | |
| Russian Medical Academy of Post-graduate Education | Recruiting |
| Moscow, Russian Federation | |
| State Educational Institution for Higher Professional Education | Recruiting |
| Saratov, Russian Federation | |
| Saint-Petersburg State Health Care Institution | Recruiting |
| Saint Petersburg, Russian Federation | |
| Federal State Institution | Recruiting |
| Moscow, Russian Federation | |
| Ukraine | |
| Donetsk Regional Clinical Children's Hospital | Recruiting |
| Donetsk, Ukraine | |
| Kharkiv Regional Clinical Children's Hospital | Recruiting |
| Kharkiv, Ukraine | |
| Zaporizhzhya Regional Paediatric Hospital | Recruiting |
| Zaporizhya, Ukraine | |
| Ukrainian Children's Specialized Clinical Hospital | Recruiting |
| Kiev, Ukraine | |
| Institute of Endocrinology and Metabolism | Recruiting |
| Kiev, Ukraine | |
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
| Responsible Party: | Ferring Pharmaceuticals ( Clinical Development Support ) |
| Study ID Numbers: | FE999905 CS07, 2008-004849-28 |
| Study First Received: | April 17, 2009 |
| Last Updated: | February 5, 2010 |
| ClinicalTrials.gov Identifier: | NCT00884000 History of Changes |
| Health Authority: | Israel: Ministry of Health; Israel: Ethics Commission; Ukraine: Ministry of Health; Ukraine: State Pharmacological Center - Ministry of Health; Romania: National Medicines Agency; Romania: National Authority for Scientific Research; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Poland: Ministry of Health; Hungary: National Institute of Pharmacy; Germany: German Institute of Medical Documentation and Information; Germany: Ethics Commission; Russia: Ethics Committee; Russia: FSI Scientific Center of Expertise of Medical Application; Russia: Ministry of Health and Social Development of the Russian Federation; Russia: Pharmacological Committee, Ministry of Health |
|
Dwarfism Bone Diseases, Endocrine Hypothalamic Diseases Pituitary Diseases Nervous System Diseases Endocrine System Diseases Central Nervous System Diseases |
Dwarfism, Pituitary Brain Diseases Bone Diseases Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental |