Trial Outcomes & Findings for A Comparison of 5 Low Volume Bowel Preparations (NCT NCT01719653)

Results Overview

The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

1079 participants

Primary outcome timeframe

At completion of colonoscopy - day 1

Results posted on

2017-03-24

Participant Flow

Participant milestones

Participant milestones
Measure	MiraLAX 306 g (Day-Prior) MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 357 g (Day-Prior) MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 306 g (Split-Dose) MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MoviPrep (Split-Dose) MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids. MoviPrep: MoviPrep consumed as described in each arm.	SUPREP (Split-Dose) SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids. SUPREP: SUPREP consumed as described in each arm.
Overall Study STARTED	209	213	218	218	221
Overall Study COMPLETED	200	200	200	200	200
Overall Study NOT COMPLETED	9	13	18	18	21

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Comparison of 5 Low Volume Bowel Preparations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MiraLAX 306 g (Day-Prior) n=200 Participants MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 357 g (Day-Prior) n=200 Participants MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 306 g (Split-Dose) n=200 Participants MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MoviPrep (Split-Dose) n=200 Participants MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids. MoviPrep: MoviPrep consumed as described in each arm.	SUPREP (Split-Dose) n=200 Participants SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids. SUPREP: SUPREP consumed as described in each arm.	Total n=1000 Participants Total of all reporting groups
Age, Continuous	60.9 years STANDARD_DEVIATION 12.7 • n=5 Participants	61.3 years STANDARD_DEVIATION 12.4 • n=7 Participants	59.1 years STANDARD_DEVIATION 11.3 • n=5 Participants	60.1 years STANDARD_DEVIATION 11.4 • n=4 Participants	60.6 years STANDARD_DEVIATION 11.2 • n=21 Participants	60.4 years STANDARD_DEVIATION 11.8 • n=10 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	99 Participants n=7 Participants	101 Participants n=5 Participants	97 Participants n=4 Participants	99 Participants n=21 Participants	495 Participants n=10 Participants
Sex: Female, Male Male	101 Participants n=5 Participants	101 Participants n=7 Participants	99 Participants n=5 Participants	103 Participants n=4 Participants	101 Participants n=21 Participants	505 Participants n=10 Participants
Region of Enrollment United States	200 participants n=5 Participants	200 participants n=7 Participants	200 participants n=5 Participants	200 participants n=4 Participants	200 participants n=21 Participants	1000 participants n=10 Participants

PRIMARY outcome

Timeframe: At completion of colonoscopy - day 1

The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).

Outcome measures

Outcome measures
Measure	MiraLAX 306 g (Day-Prior) n=200 Participants MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 357 g (Day-Prior) n=200 Participants MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 306 g (Split-Dose) n=200 Participants MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MoviPrep (Split-Dose) n=200 Participants MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids. MoviPrep: MoviPrep consumed as described in each arm.	SUPREP (Split-Dose) n=200 Participants SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids. SUPREP: SUPREP consumed as described in each arm.
Chicago Bowel Preparation Scale Chicago BPS Total Score	33.54 units on a scale Standard Deviation 4.28	34.00 units on a scale Standard Deviation 4.25	34.67 units on a scale Standard Deviation 3.58	34.95 units on a scale Standard Deviation 3.39	35.16 units on a scale Standard Deviation 2.34
Chicago Bowel Preparation Scale Modified Chicago BPS Total Score	31.82 units on a scale Standard Deviation 3.59	32.14 units on a scale Standard Deviation 3.69	32.33 units on a scale Standard Deviation 2.93	32.54 units on a scale Standard Deviation 2.92	32.65 units on a scale Standard Deviation 1.72
Chicago Bowel Preparation Scale Chicago BPS Fluid Score	0.90 units on a scale Standard Deviation 0.83	1.03 units on a scale Standard Deviation 0.89	1.84 units on a scale Standard Deviation 0.90	1.45 units on a scale Standard Deviation 0.82	1.30 units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: At completion of colonoscopy - day 1

The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).

Outcome measures

Outcome measures
Measure	MiraLAX 306 g (Day-Prior) n=200 Participants MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 357 g (Day-Prior) n=200 Participants MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MiraLAX 306 g (Split-Dose) n=200 Participants MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy. MiraLAX: MiraLAX consumed as described in each arm. Gatorade: Gatorade consumed as described in each arm.	MoviPrep (Split-Dose) n=200 Participants MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids. MoviPrep: MoviPrep consumed as described in each arm.	SUPREP (Split-Dose) n=200 Participants SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids. SUPREP: SUPREP consumed as described in each arm.
Boston Bowel Preparation Scale	8.39 units on a scale Standard Deviation 1.36	8.57 units on a scale Standard Deviation 1.16	8.66 units on a scale Standard Deviation 1.16	8.80 units on a scale Standard Deviation 1.04	8.80 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: At completion of colonoscopy - day 1

The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.