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.
Minimum age: 3 Years.
Maximum age: 11 Years.
Gender(s): Both.
Semmelweiss University, 1st dept of paediatrics, Budapest, Hungary
Szent Janos Kh Budai, Budapest, Hungary
Petz Country Teaching Hospital, Gyor, 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, Nasik, 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, Beer Sheva, Israel
Western Galilee Medical Center, Nahariya, Israel
Schneider Children's Medical Center of Israel, Petach 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", Bucuresti, Romania
Spitalul Clinic Municipal "Filantropia", Craiova, Romania
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon", Iasi, Romania
Spitalul Clinic Judetean Mures, Targu Mures, Romania
Paediatric Endocrinology/Medicali's SRL, Timisoara, Romania
Spitalul Clinic pentru Copii Louis Turcanu, Timisoara, Romania
State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV, Kazan, Russian Federation
Federal State Institution, Moscow, Russian Federation
Russian Medical Academy of Post-graduate Education, Moscow, Russian Federation
Saint-Petersburg State Health Care Institution, Saint Petersburg, Russian Federation
State Educational Institution for Higher Professional Education, Saratov, Russian Federation
State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV, Tomsk, Russian Federation
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), Odessa, Ukraine
Zaporizhzhya Regional Paediatric Hospital, Zaporizhya, Ukraine