NCT01595932|CompletedPhase 4DMC
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Sponsor study identifier
interventional
52
0 countries
N/A
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
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.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 2010
Actual (reported)May 2010
Actual (reported)May 9, 2012
Actual (reported)May 10, 2012
Actual (reported)Efficacy
Global distress associated with gas-related symptoms (bloating, flatulance, abdominal distension and abdominal spasm): data collected by parents or patients on a daily diary chart, 3 time/daily by using a validated visual score scale (Faces Pain Scale-Revised).
5 weeks of observation
Clinical tolerability
treatment: 2 weeks
Efficacy
5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
Efficacy
5 weeks of observation (baseline: 1 week; treatment: 2 weeks; follow-up: 2 weeks)
Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks: children \< 20kg: 4 drops; children \> 20kg and \< 40kg: 8 drops; children \> 40kg: 1 tablet.
Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks: children \< 20kg: 4 drops; children \> 20kg and \< 40kg: 8 drops; children \> 40kg: 1 tablet.
Di Nardo G, Oliva S, Ferrari F, Mallardo S, Barbara G, Cremon C, Aloi M, Cucchiara S. Efficacy and tolerability of alpha-galactosidase in treating gas-related symptoms in children: a randomized, double-blind, placebo controlled trial. BMC Gastroenterol. 2013 Sep 24;13:142. doi: 10.1186/1471-230X-13-142.
52 participants (actual enrollment reported by the registry).
First Submitted
May 9, 2012
First Posted
May 10, 2012
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
May 2010
Actual (reported)Study Completion
May 2010
Actual (reported)Last Updated
May 10, 2012
Record last verified: 2012-05
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Source: ClinicalTrials.gov.
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