Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment

• Status: Withdrawn
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase IIa study is designed as a multi-centre, single country, 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 ≥ 6 weeks and < 4 months

• No adequate response to conventional pharmacological or non-pharmacological treatment alternatives for infant colic

• Infants exclusively breast-fed.

• Normal growth

• 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)

• Formula fed or mixed fed infants.