A Study of Zomacton in Children With Growth Hormone Deficiency
- Registration Number
- NCT00884000
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 165
- Signed informed consent
- Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
- Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of <10ng/ml pr lower if so required by the country specific board(s)
- Height SDS <-2 SD of ref value for CA
- Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
- Height recorded for at least 6 months but not more than 18 months of pre-screening
- The difference between CA-BA≥ 1
- A positive locally performed GH stimulation test (defined as a peak plasma level of<9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening
- BA above 9 yrs for girls and 10 yrs for boys
- Puberty Tanner stage >1
- Weight <12 Kg at screening
- Any prior treatment with GH
- Closed epiphysis
- Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
- Any other diagnosed or suspected endocrine or metabolic disorder
- Any diagnosed or suspected sever chronic disease
- Clinical signs of dysmorphic features, malformations or mental retardations
- Growth failure due to other disorders
- Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
- Diagnosed malignant disease
- Any abnormal CS lab results that requires further investigation
- Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial
- Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Genotropin - 2 Zomacton -
- Primary Outcome Measures
Name Time Method Height Velocity 12 months
- Secondary Outcome Measures
Name Time Method BA (Bone Age) 12 months Change in IGF-1 and IGFBP-3 12 months Anti-hGH AB 12 months CS Changes in safety lab, physical examination and vital signs 12 months Height SDS 12 months Height velocity SDS 12 months AE and tolerability 12 months
Trial Locations
- Locations (43)
University of Szeged
🇭🇺Szeged, Hungary
Petz Country Teaching Hospital
🇭🇺Gyor, Hungary
TOTALL Diabetes Hormone Institute
🇮🇳Indore, India
Spitalul Clinic pentru Copii Louis Turcanu
🇷🇴Timisoara, Romania
State Educational Institution of Higher Professional Education "Kazan State Medical University of ROSZDRAV
🇷🇺Kazan, Russian Federation
Endocare Clinic
🇮🇳Nasik, India
Health & Research Centre
🇮🇳Trivandrum, India
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
Markusovszkty Teaching Hospital
🇭🇺Szombathely, Hungary
Associates in Clinical Endocrinology Education and Research (ACEER)
🇮🇳Chennai, India
Western Galilee Medical Center
🇮🇱Nahariya, Israel
Saint-Petersburg State Health Care Institution
🇷🇺Saint Petersburg, Russian Federation
Odessa National Medical University - (Located at Odessa Region Children's Clinical Hospital)
🇺🇦Odessa, Ukraine
Zaporizhzhya Regional Paediatric Hospital
🇺🇦Zaporizhya, Ukraine
Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital
🇮🇳Pune, India
Apollo Hospitals
🇮🇳Hyderabad, India
KEM Hospital
🇮🇳Mumbai, India
Prince Aly Khan Hospital
🇮🇳Mumbai, India
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
Dana Children's Hospital - Tel-Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
State Educational Institution for Higher Professional Education
🇷🇺Saratov, Russian Federation
Semmelweiss University, 1st dept of paediatrics
🇭🇺Budapest, Hungary
Haemek Medical Center
🇮🇱Afula, Israel
Soroka University Medical Center
🇮🇱Beer Sheva, Israel
Kaplan Medical Center
🇮🇱Rehovot, Israel
Wojewódzki Szpital Dziecięcy im. J.Brudzińskiego w Bydgoszczy
🇵🇱Bydgoszcz, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk
🇵🇱Gdansk, Poland
Uniwersytecki Szpital Dziecięcy w Krakowie
🇵🇱Krakow, Poland
Federal State Institution
🇷🇺Moscow, Russian Federation
Paediatric Endocrinology/Medicali's SRL
🇷🇴Timisoara, Romania
State Educational Institution of Higher Professional Education "Siberian State Medical University of ROSZDRAV
🇷🇺Tomsk, Russian Federation
Donetsk Regional Clinical Children's Hospital
🇺🇦Donetsk, Ukraine
Russian Medical Academy of Post-graduate Education
🇷🇺Moscow, Russian Federation
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
Szent Janos Kh Budai
🇭🇺Budapest, Hungary