Trial Outcomes & Findings for Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy (NCT NCT01170754)

Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy

The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely. The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment: 0 = Unprepared colon segment with mucosa not seen due to solid stool. 1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen. 2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid 3. = clear colon without staining

Sodium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Potassium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Chloride level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Bicarbonate level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

BUN level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Creatinine level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Glucose level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Calcium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Magnesium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Phosphorus level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.

Analysis includes a sub-group of subjects who drank \>75% of the preparation and adhered to a clear liquid diet (Per Protocol). The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment: