NCT01073943

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

A Randomized, Assessor-Blinded, Multi-Center Study Investigating the Efficacy, Safety and Tolerability of "Day Before" PicoPrep™ for Oral Administration Versus HalfLytely® for Colon Cleansing in Preparation for Colonoscopy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 603 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Subjects undergoing an elective complete colonoscopy will randomly receive either PicoPrep: 2-sachets for oral solution in two divided doses given in the afternoon (first dose - sachet) and 6 hours later in the evening (second dose - sachet), given the day before the procedure or HalfLytely: for oral solution and two 5 mg Bisacodyl tablets, given the day before the procedure to evaluate its effectiveness, tolerability and safety.

Conditions

• Bowel Preparation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-05-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-02-23
• Last updated: 2012-10-30
• Results posted: 2012-09-11

Locations

11 sites across 1 country: United States