603
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. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.
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.
Florida Clinical Research Group, Clearwater
Investigational site, Hollywood
Nature Coast Clinical Research, Inverness
Gastroenterology Associates, LLC, Baton Rouge
Louisiana Research Center, Shreveport
Investigative Clinical Research, Annapolis
NJ Physicians, LLC, Passaic
Vital re:Search, Inc, Greensboro
Gastroenterology Research Consultants of Greater Cincinnati, Cincinnati
Albert Einstein Medical Center, Philadelphia
Gastroenterology Associates, Kingsport
Lead Sponsor
Ferring Pharmaceuticals
INDUSTRY