Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 试验地点
- 8
- 主要终点
- Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.
研究概览
简要总结
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.
详细描述
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.
Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.
In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.
This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.
The experimental clinical phase encompasses the following periods:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Weeks 至 20 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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"
- •Age > 4 weeks and < 20 weeks
- •Infants breast-fed mixed fed or formula fed with a stable dietary regimen
- •Normal growth
- •History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
- •Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.
排除标准
- •Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
- •Suspect of gastroesophageal reflux disease (GERD)
- •Suspect of cow milk allergy.
研究组 & 干预措施
Nepadutant Low Dose
干预措施: Nepadutant oral solution (Drug)
Nepadutant High Dose
干预措施: Nepadutant oral solution (Drug)
Placebo
干预措施: Placebo matching Nepadutant oral solution (Drug)
结局指标
主要结局
Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline.
时间窗: Baseline and one week
Efficacy assessment to be measured through "baby's day" diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).
次要结局
- Percentage of 'Responder' Babies at the End of Treatment Period.(baseline and one week)
- Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline(1 week)
- Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline(10 days)
- Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline(1 day)
- Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test.(up to four weeks)