Trials Sponsors Conditions Drugs Pricing

Conditions

Infantile Colic

Keywords

Infantile Colictachykinin antagonistNepadutant

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 solutionDrug

Oral administration once daily for 7 days

Nepadutant Low Dose

Nepadutant oral solutionDrug

Oral administration once daily for 7 days

Nepadutant High Dose

Eligibility Criteria

Age4 Weeks - 20 Weeks

Sexall

Healthy VolunteersNo

Age GroupsChild (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

Sponsors & Collaborators

Menarini Group
Industrylead

Study Sites (9)

Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München

München, 80337, Germany

Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny

Lublin, 20-093, Poland

Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology

Moscow, 117997, Russia

Moscow State Healthcare Institution Municipal Pediatric health center № 10

Moscow, 119331, Russia

Moscow State Medical University

Moscow, 119991, Russia

Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology

Moscow, 123317, Russia

MeSH Terms

Conditions

Colic

Interventions

MEN 11420

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

Title: Dr. Angela Capriati
Organization: Menarini Ricerche

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

Enrollment

115 participants (actual enrollment reported by the registry).

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 2010

Date type not reported

This date has not been verified as actual or estimated.

Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Nepadutant Low Dose

Nepadutant High Dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (3)

Nepadutant Low Dose

Nepadutant High Dose

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (9)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations