Efficacy and Tolerability of α-galactosidase in Treating Gas-related Symptoms in Children
1 other identifier
interventional
52
0 countries
N/A
Brief Summary
The aim of this study was to evaluate the efficacy and tolerability of α-galactosidase in pediatric patients with predominant gas-related symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2009
Shorter than P25 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 9, 2012
CompletedFirst Posted
Study publicly available on registry
May 10, 2012
CompletedMay 10, 2012
May 1, 2012
11 months
May 9, 2012
May 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (3)
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)
Study Arms (2)
placebo
PLACEBO COMPARATORα-galactosidase
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- pediatric out-patients with gas-related disturbances at least once per week over the last 12 weeks.
You may not qualify if:
- suspected episodes of hypersensitivity or allergy;
- chronic organic disorders (by clinical history, physical examination, laboratory tests);
- use of drug affecting the GI motility during the previous 4 weeks;
- inability of the parent to comprehend the full nature and purpose of the study and unwillingness to co-operate with the Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 24063420DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
May 9, 2012
First Posted
May 10, 2012
Study Start
June 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 10, 2012
Record last verified: 2012-05