NCT00174460已完成2 期
Somatropin Therapy For Short Children Born Of Premature Gestation, A Controlled, Prospective Randomized, Multicenter Study With An Untreated Control Group.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Height Standard Deviation Score (SDS) After 1 Year
研究概览
简要总结
Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- •Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
- •Girls: Tanner stage 1 breast development
- •Boys: Testis volume <= 3ml
- •Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
- •(In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)
- •Height <=-2 SD for chronological age (Brandt/Reinken).
- •Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).
- •Premature born defined as <=1500 g birth weight.
- •GH sufficiency (GH level > 7 ug/l following any routine GH stimulation test).
- •Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.
排除标准
- •Subjects presenting with any of the following will not be included in the trial:
- •Other endocrine diseases except for well substituted hypothyroidism.
- •Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
- •Positive GAD and IA-2 antibodies (for type 1 diabetes).
- •History of malignancy
- •Children who meet all of the following 4 criteria:
- •actual body height < -2,5 SDS (Brandt/Reinken) and parent adjusted target height < -1 SDS (Hermanussen and Cole, 2003)
- •length and/or body weight retardations adjusted to gestational age at birth < -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
- •children with chronological age > = 4 years and
- •growth velocity < 0 SDS during the last year before inclusion.
- •Chromosomal aberrations or syndromes.
- •Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
- •Severe hemiparesis and severe CNS defects
- •Retinopathia > third degree or laser treatment as newborns.
- •Participation in any other clinical trial during active treatment phase.
- •Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
研究组 & 干预措施
Treatment Arm
Active Comparator
干预措施: Somatropin (Drug)
Treatment Arm
Active Comparator
干预措施: Control Arm (Other)
结局指标
主要结局
Change in Height Standard Deviation Score (SDS) After 1 Year
时间窗: Baseline to 1 year (Month 12)
Change in Height SDS after 1 year where SDS=height minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year
时间窗: Baseline to 1 year (Month 12)
Change in Growth Velocity (GV) SDS after 1 year where SDS=GV minus mean (age-and sex-matched reference) divided by SD (age and sex-matched reference).
次要结局
- Change From Baseline in Growth Velocity After 1 Year and After 2 Years(Baseline, Month 12, Month 24)
- Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Triceps(Baseline, Month 12, Month 24)
- Change From Baseline in Bone Stability Using pQCT After 1 Year and After 2 Years: Strength-strain Index (SSI)(Baseline, Month 12, Month 24)
- Number of Participants With Change in Insulin Sensitivity: Control Arm(Baseline, Month 36)
- Growth Curve Comparison Based on Height SDS: Control Arm(Month 36)
- Growth Curve Comparison Based on Height: Control Arm(Month 36)
- Change From Baseline in Height After 1 Year and After 2 Years(Baseline, Month 12, Month 24)
- Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Subscapular(Baseline, Month 12, Month 24)
- Change From Baseline in Growth Velocity SDS After 2 Years(Baseline, Month 24)
- Growth Curve Comparison Based on Height(Month 12, Month 24)
- Change From Baseline in Height SDS After 2 Years(Baseline, Month 24)
- Change From Baseline in Muscle Strength: Hand Grip SDS After 1 Year and After 2 Years(Baseline, Month 12, Month 24)
- Growth Curve Comparison Based on Height SDS(Month 12, Month 24)
- Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Thickness (CT)(Baseline, Month 12, Month 24)
- Number of Participants With Change in Insulin Sensitivity: Somatropin(Baseline, Month 24)
- Change From Baseline in Body Composition (Skinfold Thickness) After 1 Year and After 2 Years: Suprailiac(Baseline, Month 12, Month 24)
- Change From Baseline in Volumetric Cortical Bone Mineral Density (BMD) Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and After 2 Years(Baseline, Month 12, Month 24)
- Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Cortical Cross-sectional Area (CSA)(Baseline, Month 12, Month 24)
- Change From Baseline in Bone Structure Using Peripheral Quantitative Computed Tomography (pQCT) After 1 Year and 2 Years: Total Cross-sectional Area (CSA)(Baseline, Month 12, Month 24)
- Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Muscle Cross-sectional Area (CSA)(Baseline, Month 12, Month 24)
- Change From Baseline in Bone Structure Using pQCT After 1 Year and 2 Years: Marrow Area (MA)(Baseline, Month 12, Month 24)
研究者
研究点 (1)
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