Preliminary Efficacy and Safety Study of Oral Nepadutant in Infant Colic - Full Text View

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 ]

Estimated Enrollment:	120
Study Start Date:	November 2010
Estimated Study Completion Date:	March 2014
Estimated Primary Completion Date:	November 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

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

Contacts

Contact: Angela Capriati, MD

+39 055 5680 ext 9990

acapriati@menarini-ricerche.it

Locations

United States, Georgia
Children's Center for Digestive Health Care	Withdrawn
Atlanta, Georgia, United States, 30342
United States, Texas
DCT- Genesis Healthy Texan, LLC	Withdrawn
Dallas, Texas, United States, 75230
Germany
Klinik für Kinderheilkunde und Jugendmedizin Medizinische Hochschule	Withdrawn
Hannover, Germany
Dr. von Haunersches Kinderspital Ludwig Maximilians Universität München	Recruiting
München, Germany, 80337
Contact: Sibylle Koletzko, MD +49 89 5160 ext 7855 nocry@med.lmu.de
Contact: Katharina Werkstetter, M.Sc. +49-89-5160 ext 3680 nocry@med.lmu.de
Principal Investigator: Sibylle Koletzko, MD
Chefarzt Klinik für Kinder- und Jugendmedizin Klinikum Ernst von Bergmann gemeinnützige GmbH	Withdrawn
Postdam, Germany, 14467
Poland
Gastromed	Withdrawn
Bialystok, Poland, 15-482
Instytut Centrum Zdrowia Matki Polki III Klinika Pediatrii	Withdrawn
Lodz, Poland, 93-338
Klinika Patologii Noworodkow, Niemowlat I Kardiologii, Dzieciecy Szpital Kliniczny	Terminated
Lublin, Poland, 20-093
Prywatna Przychodnia Lekarska	Withdrawn
Rzeszow, Poland, 35-302
NZLA "MICHALKOWICE" Jarosz i partnerzy	Withdrawn
Siemianowice, Poland, 41-103
Clinic of Pediatrics and Gastroenterology Curie	Withdrawn
Wroclaw, Poland, 50-369
Russian Federation
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology	Recruiting
Moscow, Russian Federation, 123317
Contact: Andrey Petrovich Prodeus, MD prodeus@mail.ru
Principal Investigator: Andrey Petrovich Prodeus, MD
Federal Scientific Clinical Center of Children Hematology, Oncology and Immunology	Recruiting
Moscow, Russian Federation, 117997
Contact: Anna Yurievna Shcherbina, MD shcher26@hotmail.com
Principal Investigator: Anna Yurievna Shcherbina, MD
Moscow State Healthcare Institution Municipal Pediatric health center № 10	Recruiting
Moscow, Russian Federation, 119331
Contact: Boris Moiseevich Blokhin, MD blokhinb@gmail.com
Principal Investigator: Boris Moiseevich Blokhin, MD
Moscow State Medical University	Recruiting
Moscow, Russian Federation, 119991
Contact: Svetlana Ilyinichna Erdes, MD erdes@mma.ru
Principal Investigator: Svetlana Ilyinichna Erdes, MD
St. Petersburg State Institution of Healthcare Municipal Pediatric health center № 35	Recruiting
St. Petersburg, Russian Federation, 199191
Contact: Elena Markovna Bulatova, MD bulatova2008@gmail.com
Principal Investigator: Elena Markovna Bulatova, MD
St. Petersburg State Pediatric Medical Academy	Recruiting
St. Petersburg, Russian Federation, 194100
Contact: Anna Nikolaevna Galusyan dr.galustyan@gmail.com
Principal Investigator: Anna Nikolaevna Galusyan, MD
Sweden
Pediatrics Department of Clinical sciences Umeå university	Terminated
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:	December 12, 2012
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
MEN 11420
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013

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