Trial Outcomes & Findings for Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation (NCT NCT01063049)

NCT ID: NCT01063049

Last Updated: 2013-11-18

Results Overview

The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 600 participants
• Primary outcome timeframe: After Colonoscopy
• Results posted on: 2013-11-18

Participant Flow

Subjects had their colonoscopy performed between February 2010 and February 2011 by one of three gastroenterologists (DG, JH, and MR) with 17 to 34 years of experience. Colonoscopies were scheduled to begin between 0800 h and noon in the gastrointestinal labs at our office or two community hospitals.

Participant milestones

Measure	Nulytely Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Gatorade/Miralax + Placebo Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Gatorade/Miralax + Bisacodyl Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
Overall Study STARTED	200	200	200
Overall Study COMPLETED	200	200	200
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gatorade/Miralax With or Without Bisacodyl Versus NuLytely for Colonoscopy Preparation

Baseline characteristics by cohort

Measure	Nulytely n=200 Participants Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Gatorade/Miralax + Placebo n=200 Participants Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Gatorade/Miralax + Bisacodyl n=200 Participants Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Total n=600 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	120 Participants n=5 Participants	120 Participants n=7 Participants	120 Participants n=5 Participants	360 Participants n=4 Participants
Age, Categorical >=65 years	80 Participants n=5 Participants	80 Participants n=7 Participants	80 Participants n=5 Participants	240 Participants n=4 Participants
Age Continuous	60.2 years STANDARD_DEVIATION 13.2 • n=5 Participants	59.7 years STANDARD_DEVIATION 13.8 • n=7 Participants	61.3 years STANDARD_DEVIATION 12.5 • n=5 Participants	60.4 years STANDARD_DEVIATION 13.2 • n=4 Participants
Sex: Female, Male Female	81 Participants n=5 Participants	91 Participants n=7 Participants	99 Participants n=5 Participants	271 Participants n=4 Participants
Sex: Female, Male Male	119 Participants n=5 Participants	109 Participants n=7 Participants	101 Participants n=5 Participants	329 Participants n=4 Participants
Region of Enrollment United States	200 participants n=5 Participants	200 participants n=7 Participants	200 participants n=5 Participants	600 participants n=4 Participants

PRIMARY outcome

Timeframe: After Colonoscopy

The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).

Outcome measures

Measure	Nulytely n=200 Participants Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Gatorade/Miralax + Placebo n=200 Participants Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Gatorade/Miralax + Bisacodyl n=200 Participants Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale	7.86 units on a scale Standard Deviation 1.55	8.05 units on a scale Standard Deviation 1.28	7.99 units on a scale Standard Deviation 1.41

SECONDARY outcome

Timeframe: After Colonoscopy

Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).

Outcome measures

Measure	Nulytely n=200 Participants Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Gatorade/Miralax + Placebo n=200 Participants Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Gatorade/Miralax + Bisacodyl n=200 Participants Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
The Ottawa Scale for Colonoscopy Preparation Will be Reported and Compared Among the 3 Groups to Allow for Comparisons to Some of the Older Literature	2.80 units on a scale Standard Deviation 2.24	2.58 units on a scale Standard Deviation 2.47	2.71 units on a scale Standard Deviation 2.47

Adverse Events

Nulytely

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Gatorade/Miralax + Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Gatorade/Miralax + Bisacodyl

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nulytely n=200 participants at risk Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Gatorade/Miralax + Placebo n=200 participants at risk Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.	Gatorade/Miralax + Bisacodyl n=200 participants at risk Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
Gastrointestinal disorders post-polypectomy bleed	0.00% 0/200 • up to 1 month after colonoscopy.	0.50% 1/200 • Number of events 1 • up to 1 month after colonoscopy.	0.00% 0/200 • up to 1 month after colonoscopy.

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Gerard

Gastroenterology Services

Phone: 630 969 1167

Email: davidpgerard@comcast.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place