Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic (no-cry)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT01258153
First received: December 9, 2010
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Infantile Colic
Drug: Nepadutant oral solution
Drug: Placebo matching Nepadutant oral solution
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomised, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic

Further study details as provided by Menarini Group:

Primary Outcome Measures:
  • Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline. [ Time Frame: One week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of 'responder' babies at the end of treatment period. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • 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: 10 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 115
Study Start Date: November 2010
Study Completion Date: March 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nepadutant Low Dose Drug: Nepadutant oral solution
Oral administration once daily for 7 days
Experimental: Nepadutant High 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

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.
  Eligibility

Ages Eligible for Study:   up to 20 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258153

Locations
Germany
Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München
München, Germany, 80337
Poland
Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny
Lublin, Poland, 20-093
Russian Federation
Moscow State Medical University
Moscow, Russian Federation, 119991
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology
Moscow, Russian Federation, 123317
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology
Moscow, Russian Federation, 117997
Moscow State Healthcare Institution Municipal Pediatric health center № 10
Moscow, Russian Federation, 119331
St. Petersburg State Institution of Healthcare Municipal Pediatric health center № 35
St. Petersburg, Russian Federation, 199191
St. Petersburg State Pediatric Medical Academy
St. Petersburg, Russian Federation, 194100
Sweden
Pediatrics Department of Clinical sciences Umeå university
Umeå, Sweden, SE-901 85
Sponsors and Collaborators
Menarini Group
Investigators
Study Chair: Sibylle Koletzko, MD Dr. v. Haunersches Kinderspital Ludwig Maximilians University D- 80337 München, Germany
  More Information

No publications provided

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT01258153     History of Changes
Other Study ID Numbers: NIC-03
Study First Received: December 9, 2010
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency

Keywords provided by Menarini Group:
Infantile Colic
tachykinin antagonist
Nepadutant

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Pharmaceutical Solutions
MEN 11420
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014