- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01309009
Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment (nocry-a)
Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic Babies Not Responder to Conventional Treatments
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day.
Current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory.
In animal models, Nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that Nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit.
This phase IIa study is designed to evaluate the efficacy of Nepadutant paediatric oral solution given once daily at two doses in comparison to placebo.
The experimental clinical phase encompasses the following periods:
- Screening period (no study medication) to be done 7 to 4 days prior to randomisation
- Treatment period, lasting seven days with once daily administration
- Post treatment period, lasting seven days A safety follow-up visit will be performed approximately 1 month after the first administered dose.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 ≥ 6 weeks and < 4 months
- No adequate response to conventional pharmacological or non-pharmacological treatment alternatives for infant colic
- Infants exclusively breast-fed.
- Normal growth
- 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)
- Formula fed or mixed fed infants.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Oral administration once daily for 7 days
|
Experimental: Nepadutant High Dose
|
Oral administration once daily for 7 days
|
Experimental: Nepadutant Low Dose
|
Oral administration once daily for 7 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline.
Time Frame: one week
|
one week
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage of 'responder' babies at the end of treatment period.
Time Frame: one week
|
one week
|
Absolute change in the overall parental judgment after the first dose of treatment, at the end of treatment, and after treatment discontinuation versus baseline.
Time Frame: ten days
|
ten days
|
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.
Time Frame: up to four weeks
|
up to four weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Paolo Lionetti, MD, Servizio di Gastroenterologia dell'Azienda Ospdedaliero - Universitaria Anna Meyer di Firenze
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIC-05 (NOCRY-a)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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