Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Phase I Study to Evaluate the Oral Absorption of Nepadutant in Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Menarini Group
ClinicalTrials.gov Identifier:
NCT00655083
First received: April 3, 2008
Last updated: October 11, 2011
Last verified: October 2011
  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 through the drug recovery in urine.


Condition Intervention Phase
Infantile Colic
Infantile Functional Gastrointestinal Disorders
Drug: Nepadutant
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Evaluate the Oral Absorption, Safety, and Tolerability of Nepadutant Administered as Single Oral Doses to Infants With Colic and Other Functional Gastrointestinal Disorders

Resource links provided by NLM:


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 ]
    Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age strata 6-<12 and 12-<18 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.

  • 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 ]
    Nepadutant was measured in the 24-h urine collection post both doses (0.1 and 0.5 mg/kg dose), in the age stratum 18-24 weeks, using urinary collection/extraction from pre-weighed special fiber based diapers.


Secondary Outcome Measures:
  • Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    Number of adverse events (AE) reported by dose and age stratum 6-<12 and 12-<18 weeks.

  • Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants. [ Time Frame: one week ] [ Designated as safety issue: Yes ]
    Number of adverse events (AE) reported by dose and age stratum 18-24 weeks.


Enrollment: 21
Study Start Date: March 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nepadutant 0.1 mg/kg
Drug: Nepadutant
0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Other Name: Nepadutant
Experimental: 2
Nepadutant 0.5 mg/kg
Drug: Nepadutant
0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Other Name: Nepadutant

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 (from 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 history consistent with a diagnosis of colic or other functional gastrointestinal disorders
  • 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 and other functional gastrointestinal disorders, unless associated to symptoms which are likely to interfere with drug absorption, e.g. frequent vomiting), 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
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: NCT00655083

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, Kentucky
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
Louisville, Kentucky, United States, 40202
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Menarini Group
Investigators
Study Chair: Jeffrey L Blumer, MD, PHD Rainbow Babies and Children's Hospital
  More Information

No publications provided

Responsible Party: Menarini Group
ClinicalTrials.gov Identifier: NCT00655083     History of Changes
Other Study ID Numbers: NIC 02, Oral absorption, of Nepadutant in Infants
Study First Received: April 3, 2008
Results First Received: May 27, 2010
Last Updated: October 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Menarini Group:
Infantile colic
Abdominal Cramps
Colicky Pain
Functional gastrointestinal disorders

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

ClinicalTrials.gov processed this record on November 23, 2014