A Study of Zomacton in Children With Growth Hormone Deficiency - Full Text View

Sponsor:	Ferring Pharmaceuticals
Information provided by (Responsible Party):	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 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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:

Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency metatropic dysplasia pseudoachondroplasia

Drug Information available for: Somatropin

U.S. FDA Resources

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:	September 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1	Drug: Genotropin
Experimental: 2	Drug: Zomacton

Eligibility

Ages Eligible for Study:	3 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884000

Show 43 Study Locations

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00884000 History of Changes
Other Study ID Numbers:	FE999905 CS07, 2008-004849-28
Study First Received:	April 17, 2009
Last Updated:	February 14, 2012
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 India: Drugs Controller General of India India: Institutional Review Board

Additional relevant MeSH terms:

Dwarfism, Pituitary
Endocrine System Diseases
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine

Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 24, 2012