A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants
Completed
Menarini Group
Phase 1
The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after
single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral
absorption is evaluated through the drug recovery in urine.
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
Completed
Menarini Group
Phase 2
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.
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment
Withdrawn
Menarini Group
Phase 2
This phase IIa study is designed as a multi-centre, single country, 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.
Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance
Completed
Menarini Group
Phase 2
The present pilot study is aimed to obtain preliminary data on the effect of three ascending
oral dose levels of nepadutant on the relief of symptoms associated with feeding intolerance.
In addition, the assessment of drug exposure (PK assessment) will provide additional
information on the dose-effect relationship, thus supporting the dose selection and dosing
schedule in the future studies.
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