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

• Sponsor: Gastroenterology Services, Ltd. (Other)
• Overall Status: Completed
• CT.gov ID: NCT01063049
• Collaborator: (none)
• Enrollment: 600
• Location: 1
• Arms: 3
• Duration (Months): 12
• Patients Per Site Per Month: 50

Study Details

Study Description

Brief Summary

The purpose of this study is to compare Nulytely (or Trilyte) with a Gatorade and Miralax combination for cleaning out the colon before colonoscopy. A laxative pill called Bisacodyl may also be used with the Gatorade and Miralax to see if it helps with the clean out process. We are trying to find out if either of these methods is more acceptable to the patient and does a better job cleaning out the colon for a colonoscopy.

Condition or Disease	Intervention/Treatment	Phase
Preparation for Colonoscopy	Drug: Gatorade/Miralax; Drug: NuLytely; Drug: Bisacodyl; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Gatorade/Miralax With or Without Bisacodyl vs NuLytely for Colonoscopy Preparation
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Feb 1, 2011
• Actual Study Completion Date: Feb 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Nulytely Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	Drug: NuLytely; Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
Experimental: 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.	Drug: Gatorade/Miralax; Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.; Drug: Placebo; Placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy
Experimental: 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.	Drug: Gatorade/Miralax; Gatorade 64 oz (1/2 gallon), Miralax 306 g to be consumed the day before your colonoscopy as follows: Miralax 51 g at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.; Drug: Bisacodyl; Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy at 12 noon.

Outcome Measures

Primary Outcome Measures

1. The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale [After Colonoscopy]

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

Secondary Outcome Measures

1. 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 [After Colonoscopy]

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

Eligibility Criteria

Criteria

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

Inclusion Criteria:

1. Patients at least 18 years old planning to undergo an elective colonoscopy.

Exclusion Criteria:

1. Patients who are allergic or intolerant to any on the study drugs.

2. Pregnant patients.

3. Patients who required multiple day colon preparation in the past.

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

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 P Gerard, M.D., Gastroenterology Services, Ltd.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• On line publication of study resulting from this work.

Publications

None provided.

• Responsible Party: David Gerard, M.D., MD, Gastroenterology Services, Ltd.
• ClinicalTrials.gov Identifier: NCT01063049
• Other Study ID Numbers: 1220100180
• First Posted: Feb 5, 2010
• Last Update Posted: Nov 18, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Bisacodyl; Polyethylene glycol 3350

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Nulytely	Gatorade/Miralax + Placebo	Gatorade/Miralax + Bisacodyl
Arm/Group Description	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	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 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.
Period Title: Overall Study
STARTED	200	200	200
COMPLETED	200	200	200
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Nulytely	Gatorade/Miralax + Placebo	Gatorade/Miralax + Bisacodyl	Total
Arm/Group Description	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	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 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 of all reporting groups
Overall Participants	200	200	200	600
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	120 60%	120 60%	120 60%	360 60%
>=65 years	80 40%	80 40%	80 40%	240 40%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.2 (13.2)	59.7 (13.8)	61.3 (12.5)	60.4 (13.2)
Sex: Female, Male (Count of Participants)
Female	81 40.5%	91 45.5%	99 49.5%	271 45.2%
Male	119 59.5%	109 54.5%	101 50.5%	329 54.8%
Region of Enrollment (participants) [Number]
United States	200 100%	200 100%	200 100%	600 100%

Outcome Measures

1. Primary Outcome

Title	The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale
Description	The Boston Bowel Preparation Scale measures cleanliness of the colon on a scale of 0 (very poor) to 9 (excellent).
Time Frame	After Colonoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nulytely	Gatorade/Miralax + Placebo	Gatorade/Miralax + Bisacodyl
Arm/Group Description	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	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 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.
Measure Participants	200	200	200
Mean (Standard Deviation) [units on a scale]	7.86 (1.55)	8.05 (1.28)	7.99 (1.41)

2. Secondary Outcome

Title	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
Description	Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).
Time Frame	After Colonoscopy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Nulytely	Gatorade/Miralax + Placebo	Gatorade/Miralax + Bisacodyl
Arm/Group Description	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.	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 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.
Measure Participants	200	200	200
Mean (Standard Deviation) [units on a scale]	2.80 (2.24)	2.58 (2.47)	2.71 (2.47)

Adverse Events

Time Frame	up to 1 month after colonoscopy.
Arm/Group Title	Nulytely		Gatorade/Miralax + Placebo		Gatorade/Miralax + Bisacodyl
Arm/Group Description	Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.		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 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.
All Cause Mortality
	Nulytely		Gatorade/Miralax + Placebo		Gatorade/Miralax + Bisacodyl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Nulytely		Gatorade/Miralax + Placebo		Gatorade/Miralax + Bisacodyl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		1/200 (0.5%)		0/200 (0%)
Gastrointestinal disorders
post-polypectomy bleed	0/200 (0%)	0	1/200 (0.5%)	1	0/200 (0%)	0
Other (Not Including Serious) Adverse Events
	Nulytely		Gatorade/Miralax + Placebo		Gatorade/Miralax + Bisacodyl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/200 (0%)		0/200 (0%)		0/200 (0%)

Limitations/Caveats

Both the BBPS and OPS suffer from poorly designed scoring systems that are not easily converted into the poor/fair/good/excellent subjective rating scale, which is often used by gastroenterologists in their colonoscopy reports.

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.