NCT01309009

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Menarini Group · Industry
• Sex: All
• Age: 6 Weeks – 4 Months
• Healthy volunteers: Not accepted

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.

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 apparent cause and lasting for several hours per day. Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory. In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit. This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo. The experimental clinical phase encompasses the following periods: * Screening period (no study medication) to be done 7 to 4 days prior to randomisation * Treatment period, lasting seven days with once daily administration * Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.

Conditions

• Infantile Colic

Interventions

Type	Name	Description
DRUG	Nepadutant oral solution	Oral administration once daily for 7 days
DRUG	Placebo matching Nepadutant oral solution	Oral administration once daily for 7 days
DRUG	Nepadutant oral solution	Oral administration once daily for 7 days

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2011-03-04
• Last updated: 2012-11-06