NCT01258153.

Trial name or title	Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic (no‐cry) ClinicalTrials.gov identifier: NCT01258153 Double‐blind, randomised, placebo‐controlled, parallel‐group study to evaluate the efficacy and safety of oral administration of nepadutant in infant colic
Methods	Study type: intervention Study design: randomised, double‐blind
Participants	Inclusion criteria: Healthy infants with diagnosis of infant colic according to the following, modified Wessel criterion: "paroxysms of irritability, fussing or crying that start and stop without obvious cause for > 3 hours/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 makes infants in need of medical treatment Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antacids during the study period Exclusion criteria: Clinical evidence of allergies or other diseases that 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's milk allergy
Interventions	Number of arms: 3 Nepadutant low dose Nepadutant high dose Placebo Administration: oral; once daily for 7 days
Outcomes	Primary outcome measure: Absolute change in mean daily crying and fussing time for 3 consecutive days while on treatment vs baseline [time frame: 1 week] [designated as safety issue: no] Secondary outcome measures: Percentage of 'responder' babies at end of treatment period [time frame: 1 week ] [designated as safety issue: no] Absolute change in overall parental judgement after first dose of treatment, at the end of treatment and after treatment discontinuation vs baseline [time frame: 10 days] [designated as safety issue: no] Safety and tolerability assessed in terms of frequency and severity of adverse events (AEs) as well as frequency of clinically significant changes in physical examination findings and lab test results [time frame: up to 4 weeks] [designated as safety issue: yes]
Starting date	November 2010
Contact information	Study chair: Sybille Koletzko, Dr. v. Haunersches Kinderspital Ludwig Maximilians University D‐80337 München, Germany
Notes	This phase IIa study is designed as a multi‐centre, multi‐national, randomised, double‐blind, placebo‐controlled study in 3 parallel groups, with the aim to evaluate the efficacy and safety of nepadutant given at 2 oral doses once daily for 7 days vs placebo in the treatment of infantile colic.