608
Participants
Start Date
May 31, 2010
Primary Completion Date
October 31, 2010
Study Completion Date
October 31, 2010
PicoPrep
PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids.
HalfLytely
HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.
bisacodyl
Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
Clinical Research Associates, Huntsville
Arkansas Gastroenterology, Sherwood
Connecticut Gastroenterology Institute, Bristol
Indiana University Hospital, Indianapolis
Louisiana Research Center LLC, Shreveport
Piedmont Medical Research Associates, Winston-Salem
Hillmont GI, P.C., Flourtown
ClinSearch, Chattanooga
Blue Ridge Medical Research, Lynchburg
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY