Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep

PHASE3CompletedINTERVENTIONAL
Enrollment

603

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

October 31, 2010

Study Completion Date

October 31, 2010

Conditions
Bowel Preparation
Interventions
DRUG

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.

DRUG

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.

DRUG

bisacodyl

Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.

Trial Locations (11)

Unknown

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

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY

NCT01073943 - Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Day Before PicoPrep | Biotech Hunter | Biotech Hunter