Infant Colic MedDRA version: 14.1 Level: LLT Classification code 10021732 Term: Infant colic System Organ Class: 100000004856
Conditions
Interventions
Product Name: Nepadutant
Pharmaceutical Form: Oral solution
INN or Proposed INN: Nepadutant
CAS Number: 183747-35-5
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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 treatment. 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo ;Secondary Objective: Secondary objectives of the study are: • To assess the duration of treatment effect after end of treatment. • To assess the safety and tolerability after 7 day repeated doses. • To select the dose to be tested in the subsequent Phase II/III clinical development. • To evaluate the pharmacokinetics of Nepadutant in infants. ;Primary end point(s): Absolute change of the mean daily crying and fussing combined time as recorded on the “baby’s day” diary for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) versus baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration). | — |
Countries
Germany, Sweden
Outcome results
None listed