EUCTR2009-018218-21-DE进行中（未招募）不适用
Double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of Nepadutant in infant colic - nocry
Menarini Ricerche S.p.A.0 个研究点目标入组 120 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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. Healthy infants with diagnosis of infant colic according to the
- •following modified Wessel criterion paroxysm of irritability,
- •fussing or crying that start and stop without obvious cause for
- •>3h/day, >3 days/week for one week”, and confirmed by Crying
- •Patterns Questionnaire.
- •NOTE: At randomisation, the eligibility of patient has to be
- •confirmed also by a total of crying and/or fussing time lasting at least 6 hours as recorded on baby’s day” diary during
- •the 3 screening days (from Day -4 to Day -1).
- •2. Age > 4 weeks and < 20 weeks with a post-conceptual age
- •(PCA) > 40 weeks at the enrolment.
- •3. Infants breast-fed, mixed fed or formula fed with a stable dietary regimen and for whom no change in the dietary habit is planned until last day of diary recording (ie Day 10).
- •4. Normal growth (body weight, length, and head circumference
- •> -2 SD or 5th percentile, as per local references).
- •5. Willingness to refrain from use of antimuscarinic drugs,
- •simethicone, dimethicone or antiacids during the study period up
- •to Day 14 (i.e. until completion of post-treatment period).
- •6. Informed consent by parents (one or both, according to local
- •regulations).
- •7. Parent available to be trained to complete diaries/scales/
- •questionnaires.
- •8. Parent willing to record feeding episodes, drug administration
- •and diaries/scales/questionnaires during the study period up to
- •Day 14 (i.e. until completion of post-treatment period).
- •9. History of no adequate response to conventional treatment
- •alternatives which make the infants in need of medical
- •ONLY in case of breast fed infants (mixed or exclusively breast fed).
- •10. History of no adequate response after at least 48 hours of maternal dietary restriction.
- •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. Clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, genetic, gastrointestinal (excluding infant colic) haematological, or neurological pathology, allergy or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
- •2. Suspect of gastroesophageal reflux disease (GERD) with any of the following signs or symptom:
- •- frequent regurgitation (> 5 per day during the screening period),
- •- feeding refusal with anorexia,
- •- insufficient weight gain or failure to thrive,
- •- blood stained vomits,
- •- recurrent choking or gagging,
- •- coughing without signs of infection.
- •3. Previous major surgery or blood loss.
- •4. Any pharmacological treatment intake starting from 24 h before the baby's day diary recording at screening (ie the day before Day -4). NOTE: minerals and vitamins are allowed without any change in the posology.
- •5. Change in probiotics and herbal tea intake starting from 24 h before the baby's day diary recording at screening and up to Day 14 (i.e. until completion of the post treatment-period).
- •6. Vaccinations performed within one week prior to randomisation or planned during the treatment period.
- •7. Suspect of cow milk allergy
- •8. Use of complementary foods
- •9. increase in the crying frequency / duration as consequence of the introduction of formula milk.
研究者
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