nocry-a
Double-blind, Randomised, Placebo-controlled, Parallel Group Pilot Study to Evaluate the Efficacy and Safety of Oral Administration of Nepadutant in Infant Colic Babies Not Responder to Conventional Treatments
Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2012
Actual (reported)Study Completion
January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This phase IIa study is designed as a multi-centre, single country, 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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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.
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2, 2011
Actual (reported)March 4, 2011
Actual (reported)November 2012
Actual (reported)January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Absolute change of the mean daily crying and fussing time for three consecutive days while on treatment versus baseline.
one week
Percentage of 'responder' babies at the end of treatment period.
one week
Absolute change in the overall parental judgment after the first dose of treatment, at the end of treatment, and after treatment discontinuation versus baseline.
ten days
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.
up to four weeks
Oral administration once daily for 7 days
Paolo Lionetti, MD
Servizio di Gastroenterologia dell'Azienda Ospdedaliero - Universitaria Anna Meyer di Firenze
0 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2011
First Posted
March 4, 2011
Study Start
February 2011
Date type not reportedThis date has not been verified as actual or estimated.
Effects of Vivatlac Baby on Crying Behavior of Colicky Babies
Oral administration once daily for 7 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
November 2012
Actual (reported)Study Completion
January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 6, 2012
Record last verified: 2012-11
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Source: ClinicalTrials.gov.
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