A Comparison of 5 Low Volume Bowel Preparations

• Sponsor: Gastroenterology Services, Ltd. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01719653
• Collaborator: (none)
• Enrollment: 1,079
• Location: 1
• Arms: 5
• Duration (Months): 23
• Patients Per Site Per Month: 46.9

Study Details

Study Description

Brief Summary

The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation for Colonoscopy	Drug: MiraLAX; Other: Gatorade; Drug: MoviPrep; Drug: SUPREP	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 1079 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: MiraLAX; MiraLAX consumed as described in each arm.; Other Names: PEG-3350 ; Other: Gatorade; Gatorade consumed as described in each arm.
Experimental: 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.	Drug: MiraLAX; MiraLAX consumed as described in each arm.; Other Names: PEG-3350 ; Other: Gatorade; Gatorade consumed as described in each arm.
Experimental: 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.	Drug: MiraLAX; MiraLAX consumed as described in each arm.; Other Names: PEG-3350 ; Other: Gatorade; Gatorade consumed as described in each arm.
Active Comparator: 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.	Drug: MoviPrep; MoviPrep consumed as described in each arm.
Active Comparator: 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.	Drug: SUPREP; SUPREP consumed as described in each arm.

Outcome Measures

Primary Outcome Measures

1. Chicago Bowel Preparation Scale [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).

Secondary Outcome Measures

1. Boston Bowel Preparation Scale [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).

2. Adequate/Inadequate Scale [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion Criteria:

1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.

2. Patients who are pregnant.

3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.

4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.

5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Services	Downers Grove	Illinois	United States	60515

Sponsors and Collaborators

• Gastroenterology Services, Ltd.

Investigators

• Principal Investigator: David Gerard, MD, Gastroenterology Services, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gastroenterology Services, Ltd.
• ClinicalTrials.gov Identifier: NCT01719653
• Other Study ID Numbers: 1220121180
• First Posted: Nov 1, 2012
• Last Update Posted: Mar 24, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Gastroenterology Services, Ltd.: Colonoscopy; Bowel Preparation; MiraLAX; Gatorade; PEG-3350; MoviPrep; SUPREP; Chicago Bowel Preparation Scale; Boston Bowel Preparation Scale
• Additional relevant MeSH terms: Polyethylene glycol 3350

Study Results

Participant Flow

Arm/Group Title	MiraLAX 306 g (Day-Prior)	MiraLAX 357 g (Day-Prior)	MiraLAX 306 g (Split-Dose)	MoviPrep (Split-Dose)	SUPREP (Split-Dose)
Arm/Group Description	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 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 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 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 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.
Period Title: Overall Study
STARTED	209	213	218	218	221
COMPLETED	200	200	200	200	200
NOT COMPLETED	9	13	18	18	21

Baseline Characteristics

Arm/Group Title	MiraLAX 306 g (Day-Prior)	MiraLAX 357 g (Day-Prior)	MiraLAX 306 g (Split-Dose)	MoviPrep (Split-Dose)	SUPREP (Split-Dose)	Total
Arm/Group Description	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 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 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 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 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 of all reporting groups
Overall Participants	200	200	200	200	200	1000
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.9 (12.7)	61.3 (12.4)	59.1 (11.3)	60.1 (11.4)	60.6 (11.2)	60.4 (11.8)
Sex: Female, Male (Count of Participants)
Female	99 49.5%	99 49.5%	101 50.5%	97 48.5%	99 49.5%	495 49.5%
Male	101 50.5%	101 50.5%	99 49.5%	103 51.5%	101 50.5%	505 50.5%
Region of Enrollment (participants) [Number]
United States	200 100%	200 100%	200 100%	200 100%	200 100%	1000 100%

Outcome Measures

1. Primary Outcome

Title	Chicago Bowel Preparation Scale
Description	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).
Time Frame	At completion of colonoscopy - day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MiraLAX 306 g (Day-Prior)	MiraLAX 357 g (Day-Prior)	MiraLAX 306 g (Split-Dose)	MoviPrep (Split-Dose)	SUPREP (Split-Dose)
Arm/Group Description	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 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 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 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 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.
Measure Participants	200	200	200	200	200
Chicago BPS Total Score	33.54 (4.28)	34.00 (4.25)	34.67 (3.58)	34.95 (3.39)	35.16 (2.34)
Modified Chicago BPS Total Score	31.82 (3.59)	32.14 (3.69)	32.33 (2.93)	32.54 (2.92)	32.65 (1.72)
Chicago BPS Fluid Score	0.90 (0.83)	1.03 (0.89)	1.84 (0.90)	1.45 (0.82)	1.30 (0.91)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MiraLAX 306 g (Day-Prior), MiraLAX 357 g (Day-Prior), MiraLAX 306 g (Split-Dose), MoviPrep (Split-Dose), SUPREP (Split-Dose)
	Comments	All 5 arms were compared pair-wise. 1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.005
	Comments	Chicago BPS Total Score -- 1 was lower than 3,4,5; 2 was lower than 5. Modified Chicago BPS Total Score -- 1 were lower than 5. Chicago BPS Fluid Score -- 1 was dryer than 3,4,5; 2 was dryer than 3,4,5; 3 was wetter than 4,5.
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Boston Bowel Preparation Scale
Description	The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).
Time Frame	At completion of colonoscopy - day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MiraLAX 306 g (Day-Prior)	MiraLAX 357 g (Day-Prior)	MiraLAX 306 g (Split-Dose)	MoviPrep (Split-Dose)	SUPREP (Split-Dose)
Arm/Group Description	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 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 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 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 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.
Measure Participants	200	200	200	200	200
Mean (Standard Deviation) [units on a scale]	8.39 (1.36)	8.57 (1.16)	8.66 (1.16)	8.80 (1.04)	8.80 (0.77)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MiraLAX 306 g (Day-Prior), MiraLAX 357 g (Day-Prior), MiraLAX 306 g (Split-Dose), MoviPrep (Split-Dose), SUPREP (Split-Dose)
	Comments	All 5 arms were compared pair-wise. 1=G+PEG-306 2=G+PEG-357 3=G+PEG-Split 4=PEG+Asc-Split 5=SS-Split
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	1 was lower than 4,5.
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Adequate/Inadequate Scale
Description	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.
Time Frame	At completion of colonoscopy - day 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MiraLAX 306 g (Day-Prior)	MiraLAX 357 g (Day-Prior)	MiraLAX 306 g (Split-Dose)	MoviPrep (Split-Dose)	SUPREP (Split-Dose)
Arm/Group Description	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 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 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 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 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.
Measure Participants	200	200	200	200	200
Adequate	195 97.5%	196 98%	198 99%	197 98.5%	197 98.5%
Inadequate	5 2.5%	4 2%	2 1%	3 1.5%	3 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	MiraLAX 306 g (Day-Prior), MiraLAX 357 g (Day-Prior), MiraLAX 306 g (Split-Dose), MoviPrep (Split-Dose), SUPREP (Split-Dose)
	Comments	All 5 arms were compared pair-wise.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.005
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Arm/Group Title	MiraLAX 306 g (Day-Prior)		MiraLAX 357 g (Day-Prior)		MiraLAX 306 g (Split-Dose)		MoviPrep (Split-Dose)		SUPREP (Split-Dose)
Arm/Group Description	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 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 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 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 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.
All Cause Mortality
	MiraLAX 306 g (Day-Prior)		MiraLAX 357 g (Day-Prior)		MiraLAX 306 g (Split-Dose)		MoviPrep (Split-Dose)		SUPREP (Split-Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/200 (0%)		0/200 (0%)		0/200 (0%)		0/200 (0%)
Serious Adverse Events
	MiraLAX 306 g (Day-Prior)		MiraLAX 357 g (Day-Prior)		MiraLAX 306 g (Split-Dose)		MoviPrep (Split-Dose)		SUPREP (Split-Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/200 (0%)		0/200 (0%)		0/200 (0%)		0/200 (0%)
Other (Not Including Serious) Adverse Events
	MiraLAX 306 g (Day-Prior)		MiraLAX 357 g (Day-Prior)		MiraLAX 306 g (Split-Dose)		MoviPrep (Split-Dose)		SUPREP (Split-Dose)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	119/200 (59.5%)		122/200 (61%)		126/200 (63%)		110/200 (55%)		111/200 (55.5%)
Gastrointestinal disorders
Nausea	65/200 (32.5%)		80/200 (40%)		66/200 (33%)		65/200 (32.5%)		70/200 (35%)
Vomiting	18/200 (9%)		23/200 (11.5%)		12/200 (6%)		8/200 (4%)		13/200 (6.5%)
Abdominal Cramps/Pain	66/200 (33%)		70/200 (35%)		68/200 (34%)		75/200 (37.5%)		78/200 (39%)
Bloating	119/200 (59.5%)		122/200 (61%)		126/200 (63%)		110/200 (55%)		111/200 (55.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.