Double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of Nepadutant in infant colic - nocry
- Conditions
- Infant ColicMedDRA version: 14.1Level: LLTClassification code 10021732Term: Infant colicSystem Organ Class: 100000004856
- Registration Number
- EUCTR2009-018218-21-DE
- Lead Sponsor
- Menarini Ricerche S.p.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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: <br>• To assess the duration of treatment effect after end of treatment.<br>• To assess the safety and tolerability after 7 day repeated doses.<br>• To select the dose to be tested in the subsequent Phase II/III clinical development.<br>• To evaluate the pharmacokinetics of Nepadutant in infants.<br>;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).
- Secondary Outcome Measures
Name Time Method