Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA.
NCT00522743
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1. Boys
2. IUGR
3. Ages 10-13
4. height of at list 2.0 standard deviations below the mean height for chronological age and sex according to the 2000 standards from the Centers for Disease Control and Prevention (CDC)
5. Prepubertal (tanner stage 1) at commencement of trail
6. Peak GH above 10ng/ml in at least one provocative test for GH secretion 7.Signed informed consent
1. Growth retardation associated with malignancy, severe chronic disease, genetic
syndromes and endocrine disorders
2. Diabetes
3. Treatment with any medical product which may interfere with GH effects
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Descriptive Information | ||||
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Brief Title ICMJE | Growth and Metabolic Response to GH and GnRHa Treatment Versus GH Alone in Boys Born SGA. | |||
Official Title ICMJE | Two Arms, Open, Controlled, Prospective, Intervention Study to Evaluate the Growth and Metabolic Response to Growth Hormone and Gonadotropin-releasing Hormone Agonist Treatment Versus Growth Hormone Alone in Boys Born SGA | |||
Brief Summary | A 2-arms randomized open prospective intervention study to determine the Growth and metabolic response to growth hormone and gonadotropin-releasing hormone agonist treatment versus growth hormone alone in boys born SGA. All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d. At onset of puberty, subjects will be randomized into either combined treatment with GH and GnRHa or GH alone. | |||
Detailed Description | A 2-arms randomized open prospective intervention study including 20 boys, in order to determine the effect of growth hormone (GH) and gonadotropin-releasing hormone agonist treatment versus growth hormone (GnRHa) alone on growth and metabolic response. Objectives: The primary objective is to investigate the effect of delaying the pubertal process by pubertal suppression on growth and final height of boys who were born SGA and treated with GH. The secondary objectives are to determine the metabolic effect of the combined therapy of GH plus gonadotropin agonists to that of GH alone on the dietary intake, serum leptin, ghrelin, IGF-1, lipid and lipoprotein concentrations prior to and during treatment, and to assess the quality of life between the two groups. Study population: 20 prepubertal boys. Inclusion Criteria:
Exclusion criteria:
Trail design: A prospective, randomized controlled study assessing the impact of two years of combined treatment with GH and GnRHa on height of boys with severe growth failure due to SGA with height >2.25 SDS , compared with GH alone. All subjects will be treated with NorditropinSimplex at a dosage of 100mcg/kg/d. At onset of puberty (testicular volume greater than 4 ml in consecutive examinations) subjects will be randomized into either combined treatment with GH and GnRHa or GH alone. Methods:
The safety of growth hormone treatment will be assessed from:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | SGA and Growth | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 17 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 9 Years to 13 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Israel | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00522743 | |||
Other Study ID Numbers ICMJE | rmc073243ctil SGA boys 3243 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Prof. Moshe Phillip, Rabin Medical Center | |||
Study Sponsor ICMJE | Rabin Medical Center | |||
Collaborators ICMJE | Pfizer | |||
Investigators ICMJE |
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PRS Account | Rabin Medical Center | |||
Verification Date | July 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |