Phase 2
N=115
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic
Infantile Colic
Bottom Line
View on ClinicalTrials.gov: NCT01258153 ↗Enrolled (actual)
115
Serious AEs
0.9%
Results posted
Jun 2015
Primary outcome: Primary: Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. — 284.57; 273.6; 283.91; 185.8 Minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nepadutant oral solution (Drug); Placebo matching Nepadutant oral solution (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Menarini Group
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change of the Mean Daily Crying and Fussing Time for Three Consecutive Days While on Treatment Versus Baseline. |
284.57; 273.6; 283.91; 185.8; 154.4; 192.7 | — |
| SECONDARY Percentage of 'Responder' Babies at the End of Treatment Period. |
36.8; 55.3; 19.4 | — |
| SECONDARY Absolute Change in the Overall Parental Judgment After the First Dose of Treatment Versus Baseline |
-0.38; -0.68; -0.34 | — |
| SECONDARY Absolute Change in the Overall Parental Judgment at the End of Treatment Versus Baseline |
-1.24; -1.75; -1.23 | — |
| SECONDARY Absolute Change in the Overall Parental Judgment After Treatment Discontinuation Versus Baseline |
-1.35; -1.78; -1.39 | — |
| SECONDARY Safety and Tolerability Will be Assessed in Terms of Frequency and Severity of AEs as Well as Frequency of Clinically Significant Changes in Physical Examination and Lab Test. |
9; 6; 5 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Healthy infants with diagnosis of infant colic according to the following modified Wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for >3h/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 make the infants in need of medical treatment
- Willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period.
Exclusion Criteria
- Clinical evidence of allergies or other diseases which 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 milk allergy.
Data sourced from ClinicalTrials.gov (NCT01258153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.