Infant colic MedDRA version: 9.1 Level: LLT Classification code 10061247
Conditions
Interventions
Product Name: Nepadutant
Pharmaceutical Form: Oral solution
INN or Proposed INN: nepadutant
CAS Number: 183747-35-5
Concentration unit: µg/ml microgram(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, eligibility of patient has to be confirmed also by at least 2 days with at least 3h/day overall crying and fussing time recorded on “baby’s day” diary during the 3 day period from Day -4 to Day -1. 2. History of no adequate response to more than one conventional pharmacological or non-pharmacological treatment alternatives, such as simethicone, probiotics, herbal tea, behaviour interventions, which make the infants in need of medical treatment. 3. Age = 6 weeks and 44 weeks at the enrolment. 4. Infants exclusively breast-fed. 5. Normal growth (body weight, length, and head circumference > -2 SD or 5th percentile, as per local references). 6. 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). 7. Informed consent by parents (one or both, according to local regulations). 8. Parent available to be trained to complete diaries/scales/ questionnaires. 9. 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). 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 within one week prior to randomisation. NOTE: minerals and vitamins are allowed without any change in the posology. 5. Change in probiotics and herbal tea intake within one week prior randomisation and during the study period up to Day 14 (i.e. until completion of post-treatment period). 6. Vaccinations performed within one week prior to randomisation or planned during the treatment period. 7. Formula fed or mixed fed infants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.;Secondary Objective: • 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): Aabsolute 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
Italy
Outcome results
None listed