Clinical Trials Logo
  1. Home
  2. Colic
  3. NCT01532518

Preliminary Efficacy, Safety and Pharmacokinetics Study of Nepadutant in Infant With Feeding Intolerance

Colic Clinical Trial

Official title:
A Multicenter, Open Label, Ascending 7 Day-Repeated Dose Study to Investigate Efficacy, Safety and Pharmacokinetics of Nepadutant In Infants With Feeding Intolerance

Clinical Trial Summary

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.

Clinical Trial Description

Feeding intolerance is a transient neuro-developmental phenomenon affecting 25% to 40% of infant and toddler, with a peak at 6 weeks of age. Feeding problems include mainly vomiting, slow feeding, refusal to eat and colic. Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs and antiacids) are largely unsatisfactory. Nepadutant is postulated to have a therapeutic effect in infant colic since it reverts exaggerated intestinal motility and sensitivity induced by different stimuli through the activation of neurokinin-2 receptors, without interferring on the on physiological gastrointestinal transit. This phase IIa study is designed to test in each participant infant two out of three oral doses of nepadutant in order to measure its blood levels, safety and efficacy with each dose level to be given for 7 concecutive days. The experimental clinical phase encompasses the following periods: - Screening period (no study medication), lasting approximately 7 days prior to randomization - Treatment period, lasting fourteen days (7 days fore each dose)with once daily administration - A safety follow-up visit, approximately four weeks after start of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01532518
Study type Interventional
Source Menarini Group
Contact
Status Completed
Phase Phase 2
Start date August 2011
Completion date July 2012
View Details
See also
  Status Clinical Trial Phase
Completed NCT01849991 - Safety and Effect of L. Reuteri on Biomarkers of Inflammation in Healthy Infants With Colic Phase 1
Completed NCT01279265 - Effect of Lactobacillus Rhamnosus GG (LGG) on Infant Colic N/A
Completed NCT00177086 - Alfuzosin Hydrochloride to Promote Passage of Distal Ureteral Calculi Phase 3
Not yet recruiting NCT02577133 - Prevention of Colic With the Probiotic Lactobacillus Reuteri Phase 2/Phase 3
Recruiting NCT01715220 - Treatment of Suspected Cholelithiasis With Nitroglycerin Phase 2
Completed NCT00922727 - Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults Phase 1
Completed NCT02865564 - Effect of Lactobacillus Reuteri DSM17938 in Neonates Treated With Antibiotics N/A
Completed NCT01997593 - Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected Phase 2
Completed NCT01541046 - Lactobacillus Reuteri DSM 17938 Versus Placebo in the Treatment of Infantile Colic Phase 2
Completed NCT00929292 - Safety and Tolerance Study of Alpha-Lactalbumin Enriched and Probiotic-Supplemented Infant Formula in Infants With Colic Phase 3
Terminated NCT05554991 - Human Milk Oligosaccharide (HMO) Supplementation in Colic Management N/A
Recruiting NCT01067027 - Control of Colic in Infants by Dietary Supplementation With the Probiotic Lactobacillus Reuteri Phase 4
Recruiting NCT04983069 - Neonatal Outcome of Children With Antenatal Colic Hyperechogenicity
Recruiting NCT05685030 - Probiotics Strains for Infant Colic Phase 2
Withdrawn NCT05198700 - The Effect of Probiotics on Symptoms of Infantile Colic Phase 2
Terminated NCT02586558 - Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants N/A
Completed NCT00796523 - An Intervention to Decrease Infant Crying N/A
Completed NCT05052476 - First Line Dose-efficacy Study of Bactecal® D Liquid for Infant Colic N/A
Completed NCT02242292 - Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort Phase 2
Terminated NCT00139646 - Parecoxib in Renal Colic Phase 3