Clinical Trial: Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic Babies No
Brief 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 Summary:
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.
Sponsor: Menarini Group
Current Primary Outcome: Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline. [ Time Frame: one week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of 'responder' babies at the end of treatment period. [ Time Frame: one week ]
- Absolute change in the overall parental judgment after the first dose of treatment, at the end of treatment, and after treatment discontinuation versus baseline. [ Time Frame: ten days ]
- Safety and tolerability will be assessed in terms of frequency and severity of AEs as well as frequency of clinically significant changes in physical examination and lab test. [ Time Frame: up to four weeks ]
Original Secondary Outcome: Same as current
Information By: Menarini Group
Dates:
Date Received: March 2, 2011
Date Started: February 2011
Date Completion: January 2013
Last Updated: November 5, 2012
Last Verified: November 2012
