Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

NCT01258153 | Completed Phase 2 Results

• 1 other identifier: NIC-03
• Study Type: interventional
• Target: 115
• Locations: 4 countries
• Sites: 9

Brief Summary

This phase IIa study is designed as a multi-centre, multinational, 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.

  Efficacy assessment to be measured through "baby's day" diary recorded for three consecutive days while on treatment (i.e. starting from 6 pm on Day 4 and continued for 72 hours) vs baseline (i.e. starting from 6 pm on Day -4 until 1st treatment administration).

  Baseline and one week

Secondary Outcomes (5)

• Percentage of 'Responder' Babies at the End of Treatment Period.

  baseline and one week

• Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline

  1 day

• Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline

  1 week

• Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline

  10 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 Low Dose

EXPERIMENTAL

Drug: Nepadutant oral solution

Nepadutant High 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: 4 Weeks - 20 Weeks
• 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 \> 4 weeks and \< 20 weeks
• Infants breast-fed mixed fed or formula fed with a stable dietary regimen
• Normal growth
• History of no adequate response to conventional treatment alternatives which make the infants in need of medical treatment
• 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)
• Suspect of cow milk allergy.

Sponsors & Collaborators

• Menarini Group: lead

Study Sites (9)

Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München

München, 80337, Germany

Location

Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny

Lublin, 20-093, Poland

Location

Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology

Moscow, 117997, Russia

Location

Moscow State Healthcare Institution Municipal Pediatric health center № 10

Moscow, 119331, Russia

Location

Moscow State Medical University

Moscow, 119991, Russia

Location

Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology

Moscow, 123317, Russia

Location

St. Petersburg State Pediatric Medical Academy

Saint Petersburg, 194100, Russia

Location

St. Petersburg State Institution of Healthcare Municipal Pediatric health center № 35

Saint Petersburg, 199191, Russia

Location

Pediatrics Department of Clinical sciences Umeå university

Umeå, SE-901 85, Sweden

Location

MeSH Terms

Conditions

Colic

Interventions

MEN 11420

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Angela Capriati
• Organization: Menarini Ricerche

acapriati@menarini-ricerche.it

+39 05556809990

Study Officials

• Sibylle Koletzko, MD

  Dr. v. Haunersches Kinderspital Ludwig Maximilians University D- 80337 München, Germany

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: December 9, 2010
• First Posted: December 10, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-05

Locations

PL (1); DE (1); RU (6); SE (1)