Pilot study to evaluate the intestinal absorption, safety, tolerability, and efficacy of nepadutant administered as single oral doses in infantile colic patients

Menarini Ricerche S.p.A.0 个研究点开始时间: 2006年4月26日最近更新: 2016年8月16日

适应症

试验速览

暂无简介。

•- Healthy infants, as per medical history and physical examination, the only medical relevant condition being infant colic;
•- Age >6 weeks and < 24 weeks;
•- Diagnosis of infantile colic according to Wessel’s criterion (inconsolable crying for > 3h/day, > 3days/week, >3 weeks);
•- Term-born infants (+ 2 weeks);
•- Normal growth within the 3rd-97th percentile (weight, length, and head circumference);
•- Informed consent by parents (one or both) or legal guardian.
•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

•- Clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic), haematological, severe dermatological or neurological pathology or other diseases;
•- Previous major surgery, or blood loss.

发起方

Menarini Ricerche S.p.A.