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

Infantile Colic Clinical Trial

— nocry-a  

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 Not Responder to Conventional Treatments

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01309009
• Other study ID #: NIC-05 (NOCRY-a)
• Status: Withdrawn
• Phase: Phase 2
• First received: March 2, 2011
• Last updated: November 5, 2012
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: November 2012
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Weeks to 4 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Drug:
• Nepadutant oral solution
Oral administration once daily for 7 days
• Placebo matching Nepadutant oral solution
Oral administration once daily for 7 days
• Nepadutant oral solution
Oral administration once daily for 7 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Group

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline.		one week	No
Secondary	Percentage of 'responder' babies at the end of treatment period.		one week	No
Secondary	Absolute change in the overall parental judgment after the first dose of treatment, at the end of treatment, and after treatment discontinuation versus baseline.		ten days	No
Secondary	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.		up to four weeks	Yes