Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Percentage of subjects in each treatment group responding to treatment with a reduction from baseline in the percentage and duration of crying/fussing/irritability episodes associated with feeding after 4 weeks of treatment.
Global Symptom Assessment, as answered by Investigator and Parent/Guardian
(and 3 more...)
1 Month to 11 Months (Child)
P-GI05-109 2006-000957-23 U1111-1114-2358
May 11, 2006
July 22, 2010
Tampa, Florida, United States
Park Ridge, Illinois, United States
Shreveport, Louisiana, United States
(and 14 more...)
† Study has passed its completion date and status has not been verified in more than two years.