NCT00347022已完成4 期
A Clinical Study of Xenetix 300 in Multislice Computed Tomography (CT) Pediatric Indications
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Guerbet
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Creatinine Clearance
研究概览
简要总结
This is a clinical study of Xenetix 300 in Multislice Computed Tomography (MSCT) in pediatric indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child aged 1 year or above and 16 years or under
- •Patients with normal renal function (creatinine clearance > 60 ml/min/1.73 m2)
- •Patient requiring MSCT with contrast medium injection for diagnosis
- •Patient who has a blood sample planned in the 24 hours preceding the MSCT scan
- •Female patient with childbearing potential must have effective contraception (contraceptive pill or intrauterine device), be surgically sterilized or blood beta human chorionic gonadotropin (ßHCG) will be tested prior to product injection.
- •Parent(s) of the patient (and child with sufficient intellectual maturity) provided his/her/their written informed consent for their child to participate in the trial.
- •Patient with national health insurance
排除标准
- •Patients who have received diuretic or biguanide treatment during the 48 hours preceding the MSCT scan.
- •Patient with known allergy to iodinated contrast agent.
- •Patient treated with nephrotoxic drugs within one week before first blood sample
- •Patients planned to either undergo surgery or receive chemotherapy within 72 hours post injection (ie: before the blood test 72 hours post injection)
- •Patient received or planned to receive an iodinated contrast agent during 48 hours preceding the MSCT scan.
- •Breast feeding patient.
- •Pregnant patient.
- •Patient already included in this trial
- •Patient included in another clinical trial involving an investigational drug.
- •Patients whose degree of cooperation is incompatible with carrying out the study
研究组 & 干预措施
Xenetix
Experimental
The patient receive one injection of Xenetix 300 (300 mg of iodine/ml)
干预措施: Xenetix (Drug)
Visipaque
Active Comparator
The patient receive one injection of Visipaque 270 (270 mg of iodine/ml)
干预措施: Visipaque (Drug)
结局指标
主要结局
Creatinine Clearance
时间窗: between 48h before the contrast medium administration and 72h +/-12h after contrast medium administration
The variation of creatinine clearance before and after the product injection was measured
次要结局
未报告次要终点
研究者
研究点 (1)
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