Investigation of PicoPrep Versus HalfLytely for Bowel Preparation for Colonoscopy - Split Dose PicoPrep

PHASE3CompletedINTERVENTIONAL
Enrollment

608

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. 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.

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 (9)

Unknown

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

Sponsors
All Listed Sponsors
lead

Ferring Pharmaceuticals

INDUSTRY