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

NCT01309009 | Withdrawn Phase 2

• 1 other identifier: NIC-05 (NOCRY-a)
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infantile Colic

Keywords

Infantile Colic; Tachykinin antagonist; Nepadutant

Outcome Measures

Primary Outcomes (1)

• Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline.

  one week

Secondary Outcomes (3)

• Percentage of 'responder' babies at the end of treatment period.

  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.

  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.

  up to four weeks

Study Arms (3)

Nepadutant High Dose

EXPERIMENTAL

Drug: Nepadutant oral solution

Nepadutant Low Dose

EXPERIMENTAL

Drug: Nepadutant oral solution

Placebo

PLACEBO COMPARATOR

Drug: Placebo matching Nepadutant oral solution

Interventions

Nepadutant oral solution DRUG

Oral administration once daily for 7 days

Nepadutant Low Dose

Placebo matching Nepadutant oral solution DRUG

Oral administration once daily for 7 days

Placebo

Eligibility Criteria

• Age: 6 Weeks - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menarini Group: lead

MeSH Terms

Conditions

Colic

Interventions

MEN 11420

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Paolo Lionetti, MD

  Servizio di Gastroenterologia dell'Azienda Ospdedaliero - Universitaria Anna Meyer di Firenze

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2011
• First Posted: March 4, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: November 6, 2012

Record last verified: 2012-11