Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic

Infantile Colic Clinical Trial

— no-cry  

Official title:

Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258153
• Other study ID #: NIC-03
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2010
• Last updated: May 26, 2015
• Start date: November 2010
• Est. completion date: March 2014

Study information

• Verified date: May 2015
• Source: Menarini Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical DevicesPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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: Completed
• Enrollment: 115
• Est. completion date: March 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Weeks

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 > 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.

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)

• Suspect of cow milk allergy.

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

Locations

Country	Name	City	State
Germany	Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München	München
Poland	Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny	Lublin
Russian Federation	Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology	Moscow
Russian Federation	Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology	Moscow
Russian Federation	Moscow State Healthcare Institution Municipal Pediatric health center ? 10	Moscow
Russian Federation	Moscow State Medical University	Moscow
Russian Federation	St. Petersburg State Institution of Healthcare Municipal Pediatric health center ? 35	St. Petersburg
Russian Federation	St. Petersburg State Pediatric Medical Academy	St. Petersburg
Sweden	Pediatrics Department of Clinical sciences Umeå university	Umeå

Sponsors (1)

Lead Sponsor	Collaborator
Menarini Group

Countries where clinical trial is conducted

Germany,  Poland,  Russian Federation,  Sweden, 

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.	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	No
Secondary	Percentage of 'Responder' Babies at the End of Treatment Period.	Response is defined as a decrease of at least 50% of crying and fussing time during the last 3 days on treatment vs baseline.	baseline and one week	No
Secondary	Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline	On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for "Not at all" and 5 is "Extremely".; The question was "How frustrating to you was your baby's crying today?")	1 day	No
Secondary	Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline	On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for "Not at all" and 5 is "Extremely".; The question was "How frustrating to you was your baby's crying today?")	1 week	No
Secondary	Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline	On a daily basis parents expressed an overall judgement on the study treatment effect based on a 6 rate categorical scale from 0 to 5 (where 0 is for "Not at all" and 5 is "Extremely".; The question was "How frustrating to you was your baby's crying today?")	10 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.	Safety and tolerability will be assessed for the Safety Population (all patients who received the study drug) 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