EUCTR2009-018218-21-DE
Active, not recruiting
Not Applicable
Double-blind, randomised, placebo-controlled, parallel group study to evaluate the efficacy and safety of oral administration of Nepadutant in infant colic - nocry
Menarini Ricerche S.p.A.0 sites120 target enrollmentApril 1, 2010
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Menarini Ricerche S.p.A.
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
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, 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.
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.
Outcomes
Primary Outcomes
Not specified
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