EUCTR2005-001750-25-NL进行中（未招募）不适用
Efficacy and Safety of Somatropin in Combination with Leuprorelin Compared to Somatropin Alone and to an Untreated Control Group in Pubertal Children with Idiopathic Short Stature - PHOENIX
ILLY FRANCE0 个研究点目标入组 88 人开始时间: 2006年10月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male or female children with ISS defined as height = –2.5 SDS for age and gender (according to national references) or predicted adult height = –2.5 SDS at study entry based on the Bayley-Pinneau method, with a bone age reading by the central reader.
- •2.A chronological age = 8 years and < 12 years and 3 months for girls (before the 12th birthday), and = 9 years and < 14 years and 3 months for boys.
- •3.A bone age = 12.0 years for girls and = 14.0 years for boys based on a central reading of an X-ray of the left hand and wrist taken at the screening visit (V0).
- •4.Pubertal stage B2 and B3 for girls based on the Tanner method, as determined by clinical examination at the screening visit (V0).
- •5.Pubertal stage G2 and G3 for boys based on the Tanner method or a testicular length = 30 mm and < 40 mm or a testicular volume = 4 ml and < 12 ml, as determined by clinical examination at the screening visit (V0).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Growth hormone deficiency (GHD) based on two GH stimulation tests performed in the 3 years before the screening visit resulting in both GH values = 20 mIU/L (depending on the conversion factor, usually: 10 ng/ml).
- •Note: one stimulation test with a GH peak value > 20 mIU/L (depending on the conversion factor, usually: 10 ng/ml) is sufficient to eliminate a GHD.
- •2.Chromosomal abnormality diagnosed locally on a karyotype. For girls, the karyotype, to eliminate a Turner syndrome, is mandatory.
- •3.Small for gestational age (SGA): defined as length and/or weight at birth < –2 SDS versus normal gestational age height and weight measurements (Usher and McLean standards). Patients will not be excluded due to an unknown birth weight or length.
- •4.Has reached menarche (had her first menstrual period).
- •7.Have been currently or previously treated with any drug that may directly influence growth, such as somatropin, growth hormone releasing hormone or GnRH agonists, anabolic steroids, or aromatase inhibitors. This includes the previous completion or withdrawal from this study or any other study investigating any of these treatments.
- •8.Have any significant concomitant disease that is likely to interfere with growth or with the study, or is a known contraindication to GH treatment (malignancy, intra-cranial tumor, chronic disease such as insulin-dependent diabetes mellitus, chronic infectious disease, chronic renal insufficiency, chronic heart failure, chronic hepatic disease, chronic pulmonary disease, active rheumatological disease, psychosis, neurofibromatosis, McCune Albright syndrome, dysmorphic syndromes such as Russell-Silver syndrome, Leri-Weill syndrome, achondroplasia, etc.) Hypothyroidism correctly substituted with thyroid hormone replacement treatment is not an exclusion criterion.
- •9.Have any known contraindication to GnRHa treatment (known hypersensitivity to GnRH, to GnRH agonists or to one of its ingredients) or presents genital bleeding of undetermined cause.
- •10.Receiving systemic or inhaled glucocorticoid therapy (more than ten days of treatment during the past three months) or receiving any other drug that is likely to directly interfere with growth (see classes of prohibited drugs in the appendix of protocol). A hypothyroidism correctly substituted with thyroid hormone replacement treatment is not an exclusion criterion.
- •11.Presenting with a lumbar spine BMD < –2 SDS (Z-score) assessed by DXA carried out at the screening visit and centrally assessed.
研究者
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