Status:
COMPLETED
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
Lead Sponsor:
Menarini Group
Conditions:
Infantile Colic
Eligibility:
All Genders
4-20 years
Phase:
PHASE2
Brief Summary
This phase IIa study is designed as a multi-centre, multinational, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of Nepa...
Detailed Description
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any appare...
Eligibility Criteria
Inclusion
- 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"
- Age \> 4 weeks and \< 20 weeks
- Infants breast-fed mixed fed or formula fed with a stable dietary regimen
- Normal growth
- History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
- Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.
Exclusion
- Clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug.
- Suspect of gastroesophageal reflux disease (GERD)
- Suspect of cow milk allergy.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01258153
Start Date
November 1 2010
End Date
March 1 2014
Last Update
June 10 2015
Active Locations (9)
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1
Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München
München, Germany, 80337
2
Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny
Lublin, Poland, 20-093
3
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology
Moscow, Russia, 117997
4
Moscow State Healthcare Institution Municipal Pediatric health center № 10
Moscow, Russia, 119331