A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants - Full Text View

Sponsored by:	Menarini Group
Information provided by:	Menarini Group
ClinicalTrials.gov Identifier:	NCT00655083

Purpose

The purpose of the study is to evaluate the gastrointestinal absorption of nepadutant after single dose as oral solution (and the effect of age on its oral absorption) in infants. Oral absorption is evaluated trough the drug recovery in urine.

Condition	Intervention	Phase
Infant Colic	Drug: Nepadutant	Phase I

MedlinePlus related topics: Urine and Urination

Drug Information available for: Nepadutant

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
Official Title:	Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic

Further study details as provided by Menarini Group:

Primary Outcome Measures:

Drug concentration measurement in the urine collected by diapers along 24 hours post dose and one week after dose in all treated infants and by age and dose subgroups. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety and tolerability of single oral doses up to 0.5 mg/kg of nepadutant in infants. [ Time Frame: one week ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	March 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nepadutant 0.1 mg/kg	Drug: Nepadutant 0.1 or 0.5 mg/Kg as one single oral dose divided in three age strata (form 6 to 24 weeks old)
2: Experimental Nepadutant 0.5 mg/kg	Drug: Nepadutant 0.1 or 0.5 mg/Kg as one single oral dose divided in three age strata (form 6 to 24 weeks old)

Detailed Description:

This trial aims to evaluate the oral adsorption of nepadutant (0.1 or 0.5 mg/Kg given as one single dose as oral solution) in infants divided in three age strata (form 6 to 24 weeks old). Oral absorption is evaluated by measuring the amount of nepadutant in the urine output collected during the 24 hours after oral administration with special diapers.

Safety and tolerability of the drug will be evaluated by monitoring any changes in signs/symptoms at medical examination and vital signs during the fist 4 hours post-dose in the Hospital site and then by the parents at home up to 24 hours and 1 week post nepadutant administration.

Eligibility

Ages Eligible for Study:	6 Weeks to 24 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects will be eligible for inclusion in the study if they meet all of the following criteria:

Infants with a behavioural history consistent with a diagnosis of colic;
Age >6 weeks and < 24 weeks
At least 44 weeks post-conceptual age at enrolment
Normal growth
Informed consent by parents (one or both) or legal guardian
Caregiver available to be trained in collection and storage of used diapers
Caregiver available to record feeding episodes and defecations on the diary

Exclusion Criteria:

Subjects will be excluded from the study if they meet any of the following criteria:

Clinical evidence of major cardiovascular, respiratory, renal, hepatic, endocrine, metabolic, gastrointestinal (excluding infantile colic), haematological, severe dermatological or neurological pathology or other diseases;
Previous major surgery or blood loss.
Intake of antimuscarinic drugs, simethicone, or dimethicone 24 hours before study treatment administration.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655083

Contacts

Contact: Angela Capriati, MD, PhD	+39 05556809900	acapriati@menarini-ricerche.it
Contact: Giulia Poggiali	+39 05556809955	gpoggiali@menarini-ricerche.it

Locations

United States, Arkansas
Arkansas Children's Hospital	Recruiting
Little Rock, Arkansas, United States, 72202
Contact: Laura James, MD 501-364-1418 jameslaurap@uams.edu
Contact: Lee Howard, RN 501.364.6990 howardleee@uams.edu
Principal Investigator: Laura James, MD
United States, Kentucky
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Janice E. Sullivan, M.D. 502-629-5280 sully@louisville.edu
Principal Investigator: Janice E. Sullivan, MD
United States, Ohio
Rainbow Babies and Children's Hospital	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Jeffrey Blumer, MD Jeffrey.Blumer@UHhospitals.org
Contact: Bonnie Rosolowski, CCRC 216-844-3318 ext fax 216-844-51 Bonnie.Rosolowski@UHhospitals.org
Principal Investigator: Jeffrey Blumer, MD

Sponsors and Collaborators

Menarini Group

Investigators

Study Chair:

Jeffrey L Blumer, MD, PHD

Rainbow Babies and Children's Hospital

More Information

Responsible Party:	Menarini Group ( Angela Capriati )
Study ID Numbers:	NIC 02, Oral absorption, of Nepadutant in Infants
Study First Received:	April 3, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00655083
Health Authority:	United States: Food and Drug Administration

Keywords provided by Menarini Group:

Infantile colic
Abdominal Cramps
Colicky Pain

Study placed in the following topic categories:

MEN 11420
Signs and Symptoms
Signs and Symptoms, Digestive
Abdominal Pain

Colic
Pain
Muscle Cramp

Additional relevant MeSH terms:

Respiratory System Agents
Autonomic Agents
Therapeutic Uses
Physiological Effects of Drugs

Anti-Asthmatic Agents
Peripheral Nervous System Agents
Bronchodilator Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009