Double-blind, randomised, placebo-controlled, parallel group pilot study to evaluate the efficacy and safety of oral administration of Nepadutant in infant colic babies not responder to conventional treatments - NOCRY-a

MENARINI RICERCHE S.P.A.0 sitesDecember 22, 2010

ConditionsInfant colic MedDRA version: 9.1Level: LLTClassification code 10061247

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Infant colic
Sponsor: MENARINI RICERCHE S.P.A.
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 22, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

MENARINI RICERCHE S.P.A.

Eligibility 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 \< 4 months with a post\-conceptual age (PCA) \> 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

•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.