Pilot study to evaluate the intestinal absorption, safety, tolerability, and efficacy of nepadutant administered as single oral doses in infantile colic patients

Phase 1

Conditions: Infantile colic
MedDRA version: 1Level: 1Classification code 10021746

Registration Number: EUCTR2006-001524-39-BE

Lead Sponsor: Menarini Ricerche S.p.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Healthy infants, as per medical history and physical examination, the only medical relevant condition being infant colic;
- Age >6 weeks and < 24 weeks;
- Diagnosis of infantile colic according to Wessel’s criterion (inconsolable crying for > 3h/day, > 3days/week, >3 weeks);
- Term-born infants (+ 2 weeks);
- Normal growth within the 3rd-97th percentile (weight, length, and head circumference);
- Informed consent by parents (one or both) or legal guardian.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Clinical evidence of cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic), haematological, severe dermatological or neurological pathology or other diseases;
- Previous major surgery, or blood loss.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the oral bioavailability of two single ascending doses (0.1 and 0.5 mg/kg) of nepadutant given as oral solution and to investigate the effect of age on its oral absorption.;Secondary Objective: To evaluate the safety and tolerability of single oral up to 0.5 mg/kg doses of nepadutant in infants with colics, as compared to placebo; To investigate the effect of single up to 0.5 mg/kg doses of nepadutant on symptoms manifestation (crying) in the study population of infantile colic patients, as compared to placebo.;Primary end point(s): Oral bioavailability of nepadutant measured by detection of the drug in the urine.

Secondary Outcome Measures