Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

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 Nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Menarini Group
• Treatments: MEN 11420; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.