Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant With Colic Not Responding to Conventional Treatment (nocry-a)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01309009
Recruitment Status : Withdrawn
First Posted : March 4, 2011
Last Update Posted : November 6, 2012
Information provided by (Responsible Party):
Menarini Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infantile Colic Drug: Nepadutant oral solution Drug: Placebo matching Nepadutant oral solution Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : February 2011
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Nepadutant High Dose Drug: Nepadutant oral solution
Oral administration once daily for 7 days

Experimental: Nepadutant Low Dose Drug: Nepadutant oral solution
Oral administration once daily for 7 days

Placebo Comparator: Placebo Drug: Placebo matching Nepadutant oral solution
Oral administration once daily for 7 days

Primary Outcome Measures :
  1. Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline. [ Time Frame: one week ]

Secondary Outcome Measures :
  1. Percentage of 'responder' babies at the end of treatment period. [ Time Frame: one week ]
  2. 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 ]
  3. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01309009

Sponsors and Collaborators
Menarini Group
Study Chair: Paolo Lionetti, MD Servizio di Gastroenterologia dell'Azienda Ospdedaliero - Universitaria Anna Meyer di Firenze

Responsible Party: Menarini Group Identifier: NCT01309009     History of Changes
Other Study ID Numbers: NIC-05 (NOCRY-a)
First Posted: March 4, 2011    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012

Keywords provided by Menarini Group:
Infantile Colic
Tachykinin antagonist

Additional relevant MeSH terms:
Infant, Newborn, Diseases
Pharmaceutical Solutions
MEN 11420
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents