Trial Outcomes & Findings for A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy (NCT NCT00953017)

NCT ID: NCT00953017

Last Updated: 2012-11-30

Results Overview

Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 425 participants
• Primary outcome timeframe: measured at the time of colonoscopy
• Results posted on: 2012-11-30

Participant Flow

All pateints were recruited and enrolled at Brooke Army Medical Center in San Antonio, TX from July 1, 2009 to July 1, 2010.

NO significant events occured prior to study participant enrollment.

Participant milestones

Measure	Miralax Plus Amitiza 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Overall Study STARTED	106	107	106	106
Overall Study COMPLETED	101	101	100	101
Overall Study NOT COMPLETED	5	6	6	5

Reasons for withdrawal

Measure	Miralax Plus Amitiza 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Overall Study DId not show up for colonoscopy	4	4	5	4
Overall Study Incomplete data	1	1	0	0
Overall Study Procedure incomplete due to pain/looping	0	1	0	1
Overall Study Brown stool prior to procedure	0	0	1	0

Baseline Characteristics

A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy

Baseline characteristics by cohort

Measure	Miralax Plus Amitiza n=106 Participants 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax n=107 Participants 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax n=106 Participants 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) n=106 Participants 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy	Total n=425 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	104 Participants n=5 Participants	107 Participants n=7 Participants	106 Participants n=5 Participants	104 Participants n=4 Participants	421 Participants n=21 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants
Age Continuous	55.4 years STANDARD_DEVIATION 5.7 • n=5 Participants	53.8 years STANDARD_DEVIATION 5.4 • n=7 Participants	54.1 years STANDARD_DEVIATION 5.3 • n=5 Participants	54.2 years STANDARD_DEVIATION 6.7 • n=4 Participants	54 years STANDARD_DEVIATION 5.7 • n=21 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	48 Participants n=7 Participants	54 Participants n=5 Participants	49 Participants n=4 Participants	206 Participants n=21 Participants
Sex: Female, Male Male	51 Participants n=5 Participants	59 Participants n=7 Participants	52 Participants n=5 Participants	57 Participants n=4 Participants	219 Participants n=21 Participants
Region of Enrollment United States	106 participants n=5 Participants	107 participants n=7 Participants	106 participants n=5 Participants	106 participants n=4 Participants	425 participants n=21 Participants

PRIMARY outcome

Timeframe: measured at the time of colonoscopy

Bowel cleansing was evaluated with the Ottawa bowel preparation scale by each endoscopist during the endoscopy. Neither the endoscopist nor the endoscopy nurse was aware of the bowel preparation used prior to the colonoscopy. The Ottawa bowel preparation scale is a validated tool and was used in this study to provide a reliable quality assessment of the bowel preparation used for colonoscopy. This validated scale rates each section of the colon, the right, the mid, and the rectosigmoid colon, on a 5-point scale (0-4), as well as a global 3-point rating for overall colonic fluid (0-2). The total score ranges from 0 to 14. An excellent preparation with little fluid would score 0-3, a good preparation 4-6, while scores higher than 7 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of colonic fluid.

Outcome measures

Measure	Miralax Plus Amitiza n=101 Participants 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax n=101 Participants 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax n=100 Participants 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) n=101 Participants 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
The Cleanliness of the Prep as Measured by the Ottawa Scale	6.3 Ottawa Scale Interval 4.0 to 12.0	6.8 Ottawa Scale Interval 4.0 to 13.0	6.9 Ottawa Scale Interval 4.0 to 13.0	5.1 Ottawa Scale Interval 3.0 to 10.0

SECONDARY outcome

Timeframe: measured at check in to colonoscopy

patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)

Outcome measures

Measure	Miralax Plus Amitiza n=101 Participants 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax n=101 Participants 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax n=100 Participants 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) n=101 Participants 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Patient Satisfaction With the Prep Measured by 5 Point Likert Scale	3.8 units on a scale Standard Deviation 1.1	4.1 units on a scale Standard Deviation 0.8	4.0 units on a scale Standard Deviation 1.0	3.2 units on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: measured at the time of colonoscopy

total colonoscopy procedure time

Outcome measures

Measure	Miralax Plus Amitiza n=101 Participants 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax n=101 Participants 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax n=100 Participants 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) n=101 Participants 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Procedure Time	21.3 minutes Standard Deviation 10.2	19.3 minutes Standard Deviation 8.1	20 minutes Standard Deviation 9	18.3 minutes Standard Deviation 7.2

SECONDARY outcome

Timeframe: measured at the time of colonoscopy

Number of polyps

Outcome measures

Measure	Miralax Plus Amitiza n=101 Participants 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax n=101 Participants 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax n=100 Participants 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) n=101 Participants 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Polyps Detected	128 polyps	92 polyps	90 polyps	101 polyps

Adverse Events

Miralax Plus Amitiza

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Miralax Plus Dulcolax

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Miralax

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Golytely (Polyethylene Glycol)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Miralax Plus Amitiza n=101 participants at risk 106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax Plus Dulcolax n=101 participants at risk 107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Miralax n=100 participants at risk 106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.	Golytely (Polyethylene Glycol) n=101 participants at risk 106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
Gastrointestinal disorders Nausea	2.0% 2/101 • Number of events 2 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	3.0% 3/101 • Number of events 3 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	6.0% 6/100 • Number of events 6 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	4.0% 4/101 • Number of events 4 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'
Gastrointestinal disorders Abdominal Cramping	4.0% 4/101 • Number of events 4 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	2.0% 2/101 • Number of events 2 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	2.0% 2/100 • Number of events 2 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	4.0% 4/101 • Number of events 4 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'
Gastrointestinal disorders Abdominal Bloating	0.99% 1/101 • Number of events 1 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	2.0% 2/101 • Number of events 2 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	2.0% 2/100 • Number of events 2 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'	0.99% 1/101 • Number of events 1 • 1 year Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'

Additional Information

Dr. Michael Hjelkrem

Fort Belvoir Community Hospital

Phone: 531-231-2015

Email: mhjelkrem@yahoo.com

Results disclosure agreements

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