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A Study of Zomacton in Children With Growth Hormone Deficiency
This study is currently recruiting participants.
Verified by Ferring Pharmaceuticals, February 2010
First Received: April 17, 2009   Last Updated: February 5, 2010   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Height Velocity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height SDS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Height velocity SDS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in IGF-1 and IGFBP-3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BA (Bone Age) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anti-hGH AB [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • AE and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • CS Changes in safety lab, physical examination and vital signs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

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
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
  3. 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)
  4. Height SDS <-2 SD of ref value for CA
  5. Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
  6. Height recorded for at least 6 months but not more than 18 months of pre-screening
  7. The difference between CA-BA≥ 1
  8. 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

Exclusion Criteria:

  1. BA above 9 yrs for girls and 10 yrs for boys
  2. Puberty Tanner stage >1
  3. Weight <12 Kg at screening
  4. Any prior treatment with GH
  5. Closed epiphysis
  6. Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
  7. Any other diagnosed or suspected endocrine or metabolic disorder
  8. Any diagnosed or suspected sever chronic disease
  9. Clinical signs of dysmorphic features, malformations or mental retardations
  10. Growth failure due to other disorders
  11. Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
  12. Diagnosed malignant disease
  13. Any abnormal CS lab results that requires further investigation
  14. 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
  15. Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00884000

Contacts
Contact: Clinical Development Support DK0-Disclosure@ferring.com

Locations
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
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010