Sponsor study identifier
Secondary identifiers
interventional
21
1 country
3
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
April 3, 2008
Actual (reported)April 9, 2008
Actual (reported)May 2009
Actual (reported)May 2009
Actual (reported)August 25, 2010
Actual (reported)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.
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.
24 hours
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.
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.
24 hours
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
one week
Number of Adverse Events After Administration of Single Oral Doses up to 0.5 mg/kg of Nepadutant in Infants.
one week
Nepadutant 0.1 mg/kg
Nepadutant 0.5 mg/kg
0.1 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
0.5 mg/Kg as one single oral dose divided in three age strata (from 6 to 24 weeks old)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
Kosair Charities Pediatric Clinical Rsearch Unit University of Louisville
Louisville, Kentucky, 40202, United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
No infants aged 18-24 weeks were dosed at 0.5 mg/kg dose when the trial was stopped because of slow recruitment and drug expiration.
Jeffrey L Blumer, MD, PHD
Rainbow Babies and Children's Hospital
21 participants (actual enrollment reported by the registry).
First Submitted
April 3, 2008
First Posted
April 9, 2008
Study Start
March 2008
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
May 2009
Actual (reported)Study Completion
May 2009
Actual (reported)Last Updated
October 17, 2011
Results First Posted
August 25, 2010
Record last verified: 2011-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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