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

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-001524-39-BE

Enrollment

Unknown

Registered

2006-04-26

Start date

2006-05-24

Completion date

Unknown

Last updated

2016-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Nepadutant Product Code: MEN 11240 Pharmaceutical Form: Oral solution INN or Proposed INN: Nepadutant CAS Number: 18347-35-5 Current Sponsor code: MEN 11240 Concentration unit: mg/ml mil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Healthy infants, as per medical history and physical examination, the only medical relevant condition being infant colic; - Age >6 weeks and 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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026