Trial Outcomes & Findings for MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy (NCT NCT05054036)
NCT ID: NCT05054036
Last Updated: 2026-03-11
Results Overview
The Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
520 participants
Primary outcome timeframe
At time of procedure, approximately 45 minutes
Results posted on
2026-03-11
Participant Flow
Participant milestones
| Measure |
MoviPrep
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
263
|
|
Overall Study
Received Intervention
|
253
|
262
|
|
Overall Study
COMPLETED
|
202
|
210
|
|
Overall Study
NOT COMPLETED
|
55
|
53
|
Reasons for withdrawal
| Measure |
MoviPrep
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Overall Study
Incorrect preparation
|
4
|
1
|
|
Overall Study
Colonoscopy cancelled
|
19
|
27
|
|
Overall Study
No colonoscopy video
|
29
|
22
|
|
Overall Study
Protocol Violation
|
3
|
3
|
Baseline Characteristics
MoviPrep® Versus GoLYTELY® Bowel Preparation in Hospitalized Patients Undergoing Colonoscopy
Baseline characteristics by cohort
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
Total
n=412 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=9 Participants
|
64 years
n=9 Participants
|
64 years
n=18 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=9 Participants
|
87 Participants
n=9 Participants
|
172 Participants
n=18 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=9 Participants
|
123 Participants
n=9 Participants
|
240 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=9 Participants
|
27 Participants
n=9 Participants
|
58 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
171 Participants
n=9 Participants
|
183 Participants
n=9 Participants
|
354 Participants
n=18 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=9 Participants
|
5 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Black or African American
|
45 Participants
n=9 Participants
|
44 Participants
n=9 Participants
|
89 Participants
n=18 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=9 Participants
|
138 Participants
n=9 Participants
|
273 Participants
n=18 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=18 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=9 Participants
|
23 Participants
n=9 Participants
|
43 Participants
n=18 Participants
|
|
Region of Enrollment
United States
|
202 participants
n=9 Participants
|
210 participants
n=9 Participants
|
412 participants
n=18 Participants
|
|
Body Mass Index
<18 kg/m^2
|
6 Participants
n=9 Participants
|
11 Participants
n=9 Participants
|
17 Participants
n=18 Participants
|
|
Body Mass Index
18-24.9 kg/m^2
|
61 Participants
n=9 Participants
|
60 Participants
n=9 Participants
|
121 Participants
n=18 Participants
|
|
Body Mass Index
25-29.9 kg/m^2
|
52 Participants
n=9 Participants
|
69 Participants
n=9 Participants
|
121 Participants
n=18 Participants
|
|
Body Mass Index
30-34.9 kg/m^2
|
51 Participants
n=9 Participants
|
33 Participants
n=9 Participants
|
84 Participants
n=18 Participants
|
|
Body Mass Index
≥35 kg/m^2
|
31 Participants
n=9 Participants
|
37 Participants
n=9 Participants
|
68 Participants
n=18 Participants
|
|
Body Mass Index
Unknown
|
1 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=18 Participants
|
|
Participant Baseline ASA Score
1- Healthy patient
|
2 Participants
n=9 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=18 Participants
|
|
Comorbidities
Constipation
|
27 Participants
n=9 Participants
|
21 Participants
n=9 Participants
|
48 Participants
n=18 Participants
|
|
Participant Baseline ASA Score
2-Patient with mild systemic disease
|
21 Participants
n=9 Participants
|
29 Participants
n=9 Participants
|
50 Participants
n=18 Participants
|
|
Participant Baseline ASA Score
3-Patient with severe systemic disease
|
136 Participants
n=9 Participants
|
137 Participants
n=9 Participants
|
273 Participants
n=18 Participants
|
|
Participant Baseline ASA Score
4-Patient with severe systemic disease that is a constant threat to life
|
43 Participants
n=9 Participants
|
42 Participants
n=9 Participants
|
85 Participants
n=18 Participants
|
|
Comorbidities
Hypertension
|
139 Participants
n=9 Participants
|
138 Participants
n=9 Participants
|
277 Participants
n=18 Participants
|
|
Comorbidities
Coronary Artery Disease
|
54 Participants
n=9 Participants
|
48 Participants
n=9 Participants
|
102 Participants
n=18 Participants
|
|
Comorbidities
Congestive Heart Failure
|
50 Participants
n=9 Participants
|
43 Participants
n=9 Participants
|
93 Participants
n=18 Participants
|
|
Comorbidities
Diabetes
|
68 Participants
n=9 Participants
|
53 Participants
n=9 Participants
|
121 Participants
n=18 Participants
|
|
Comorbidities
Malignancy
|
40 Participants
n=9 Participants
|
48 Participants
n=9 Participants
|
88 Participants
n=18 Participants
|
|
Comorbidities
Chronic Kidney Disease
|
43 Participants
n=9 Participants
|
45 Participants
n=9 Participants
|
88 Participants
n=18 Participants
|
|
Comorbidities
Cirrhosis
|
26 Participants
n=9 Participants
|
30 Participants
n=9 Participants
|
56 Participants
n=18 Participants
|
|
Comorbidities
Dementia
|
2 Participants
n=9 Participants
|
0 Participants
n=9 Participants
|
2 Participants
n=18 Participants
|
|
Comorbidities
Stroke
|
16 Participants
n=9 Participants
|
18 Participants
n=9 Participants
|
34 Participants
n=18 Participants
|
|
Comorbidities
COVID
|
7 Participants
n=9 Participants
|
3 Participants
n=9 Participants
|
10 Participants
n=18 Participants
|
|
Comorbidities
Atrial Fibrillation
|
39 Participants
n=9 Participants
|
47 Participants
n=9 Participants
|
86 Participants
n=18 Participants
|
|
Medication use
Tricyclic Antidepressant
|
5 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
9 Participants
n=18 Participants
|
|
Medication use
Antihypertensive
|
141 Participants
n=9 Participants
|
156 Participants
n=9 Participants
|
297 Participants
n=18 Participants
|
|
Medication use
Antithrombotic
|
97 Participants
n=9 Participants
|
88 Participants
n=9 Participants
|
185 Participants
n=18 Participants
|
|
Medication use
Opioids
|
55 Participants
n=9 Participants
|
64 Participants
n=9 Participants
|
119 Participants
n=18 Participants
|
|
Indication for colonoscopy
Gastrointestinal Bleeding
|
112 Participants
n=9 Participants
|
116 Participants
n=9 Participants
|
228 Participants
n=18 Participants
|
|
Indication for colonoscopy
Diarrhea
|
31 Participants
n=9 Participants
|
41 Participants
n=9 Participants
|
72 Participants
n=18 Participants
|
|
Indication for colonoscopy
Malignancy Workup
|
11 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
18 Participants
n=18 Participants
|
|
Indication for colonoscopy
Abdominal Pain
|
16 Participants
n=9 Participants
|
16 Participants
n=9 Participants
|
32 Participants
n=18 Participants
|
|
Indication for colonoscopy
Colon Cancer Screening/Surveillance
|
10 Participants
n=9 Participants
|
7 Participants
n=9 Participants
|
17 Participants
n=18 Participants
|
|
Indication for colonoscopy
Inflammatory Bowel Disease
|
8 Participants
n=9 Participants
|
8 Participants
n=9 Participants
|
16 Participants
n=18 Participants
|
|
Indication for colonoscopy
Abnormal Imaging
|
20 Participants
n=9 Participants
|
27 Participants
n=9 Participants
|
47 Participants
n=18 Participants
|
|
Indication for colonoscopy
Iron Deficiency Anemia
|
43 Participants
n=9 Participants
|
52 Participants
n=9 Participants
|
95 Participants
n=18 Participants
|
|
Indication for colonoscopy
Other
|
10 Participants
n=9 Participants
|
12 Participants
n=9 Participants
|
22 Participants
n=18 Participants
|
|
Patient Location
Medical/Surgical Floor
|
187 Participants
n=9 Participants
|
183 Participants
n=9 Participants
|
370 Participants
n=18 Participants
|
|
Patient Location
Intensive Care Unit
|
6 Participants
n=9 Participants
|
9 Participants
n=9 Participants
|
15 Participants
n=18 Participants
|
|
Patient Location
Emergency Department
|
9 Participants
n=9 Participants
|
18 Participants
n=9 Participants
|
27 Participants
n=18 Participants
|
|
Diet Prior to Colonoscopy
Nil Per Os
|
23 Participants
n=9 Participants
|
21 Participants
n=9 Participants
|
44 Participants
n=18 Participants
|
|
Diet Prior to Colonoscopy
Clear Liquid Diet
|
176 Participants
n=9 Participants
|
185 Participants
n=9 Participants
|
361 Participants
n=18 Participants
|
|
Diet Prior to Colonoscopy
Other
|
3 Participants
n=9 Participants
|
4 Participants
n=9 Participants
|
7 Participants
n=18 Participants
|
PRIMARY outcome
Timeframe: At time of procedure, approximately 45 minutesThe Boston-Bowel-Preparation-Scale (BBPS) is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An adequate bowel preparation is defined as a BBPS of 6 or higher with no individual segment scoring less than a 2.
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Number of Participants With Adequate Bowel Preparation
|
111 Participants
|
111 Participants
|
SECONDARY outcome
Timeframe: At time of procedure, approximately 45 minutesBBPS assesses three segments of the colon (left, transverse, right) and scores each segment either a 1, 2, or 3 based on the ability to visualize the mucosa. Higher scores correspond to improved mucosal visibility.
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment
Transverse
|
1.91 score on a scale
Standard Deviation 0.84
|
1.90 score on a scale
Standard Deviation 0.76
|
|
Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment
Right
|
1.91 score on a scale
Standard Deviation 0.90
|
1.78 score on a scale
Standard Deviation 0.89
|
|
Mean Boston-Bowel-Preparation-Scale (BBPS) Score During Colonoscopy Withdrawal For Each Segment
Left
|
2.13 score on a scale
Standard Deviation 0.84
|
2.12 score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: At time of procedure, approximately 45 minutesThe BBPS is a validated scoring tool that assesses the three segments of the colon (left, transverse, right) and rates them from 1-3 based on the ability to visualize the mucosa. An excellent bowel preparation is defined as a BBPS score of an 8 or 9.
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Number of Participants With "Excellent" Bowel Preparation
|
58 Participants
|
47 Participants
|
SECONDARY outcome
Timeframe: At time of procedure, approximately 45 minutesNumber of participants with colonoscopies during which the cecum is successfully reached
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Cecal Intubation
|
191 Participants
|
201 Participants
|
SECONDARY outcome
Timeframe: At time of procedure, approximately 45 minutesTime from insertion of colonoscopy to reaching the cecum
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Cecal Intubation Time
|
13 Minutes
Interval 9.0 to 19.0
|
12 Minutes
Interval 7.0 to 20.0
|
SECONDARY outcome
Timeframe: At time of procedure, approximately 45 minutesTime from reaching the cecum to complete withdrawal of the colonoscope
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Colonoscopy Withdrawal Time
|
26 Minutes
Interval 17.0 to 36.0
|
24 Minutes
Interval 17.0 to 34.0
|
SECONDARY outcome
Timeframe: From start of prep to time of procedure, up to 21 hoursThe time from when the patient started the bowel preparation to the colonoscopy procedure itself.
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Time to Colonoscopy
|
17.1 Hours
Interval 15.1 to 20.0
|
17.6 Hours
Interval 15.6 to 20.8
|
SECONDARY outcome
Timeframe: After study completion, an average of 10 daysTime from admission to discharge
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Hospital Length of Stay
|
6 days
Interval 4.0 to 10.0
|
6 days
Interval 4.0 to 13.0
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 daysThe National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term from a scale of 1-5, with increasing score corresponding to increasing AE severity.
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
|
104 Participants
|
121 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How much of the bowel preparation was left in the bottle after drinking it to your best effort?"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
<25%
|
164 Participants
|
164 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
25-50%
|
12 Participants
|
20 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
50-75%
|
2 Participants
|
2 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
≥75%
|
8 Participants
|
13 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 1
Unknown/Did not answer
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "How tolerable did you find the bowel prep?"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
Acceptable
|
74 Participants
|
60 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
Easy
|
54 Participants
|
26 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
Somewhat difficult
|
34 Participants
|
78 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
Very difficult
|
24 Participants
|
35 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 2
Unknown/DId not answer
|
16 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Based on your current experience, would you be willing to drink the same prep again if you need another colonoscopy in the future?"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3
Somewhat willing
|
64 Participants
|
89 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3
Mostly willing
|
92 Participants
|
67 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3
Not willing at all
|
29 Participants
|
43 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Tolerability Question 3
Unknown/Did not answer
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bad taste in mouth"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
Moderate
|
36 Participants
|
44 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
None
|
72 Participants
|
74 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
Mild
|
54 Participants
|
60 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
Severe
|
23 Participants
|
20 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 1
Unknown/Did not answer
|
17 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Gastric fullness"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
None
|
79 Participants
|
58 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
Mild
|
41 Participants
|
43 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
Moderate
|
48 Participants
|
69 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
Severe
|
16 Participants
|
29 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 2
Unknown/Did not answer
|
18 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Lack of sleep from excessive bathroom trips"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
None
|
55 Participants
|
48 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
Mild
|
36 Participants
|
35 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
Moderate
|
52 Participants
|
58 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
Severe
|
42 Participants
|
58 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 3
Unknown/Did not answer
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Nausea/vomiting"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
None
|
133 Participants
|
148 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
Mild
|
27 Participants
|
33 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
Moderate
|
13 Participants
|
12 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
Severe
|
12 Participants
|
6 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 4
Unknown/Did not answer
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Bloating/abdominal distension/gas"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
None
|
93 Participants
|
91 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
Mild
|
52 Participants
|
55 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
Moderate
|
31 Participants
|
35 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
Severe
|
9 Participants
|
18 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 5
Unknown/Did not answer
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Abdominal pain/cramps"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
None
|
123 Participants
|
123 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
Mild
|
29 Participants
|
42 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
Moderate
|
21 Participants
|
27 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
Severe
|
11 Participants
|
6 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 6
Unknown/Did not answer
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Immediately prior to procedureThe Mayo Clinic Bowel Preparation Questionnaire is a survey consisting of questions that relate to symptoms and tolerability of bowel preparation before colonoscopy. Data presented here is for "Headache"
Outcome measures
| Measure |
MoviPrep
n=202 Participants
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 Participants
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
None
|
154 Participants
|
159 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
Mild
|
19 Participants
|
20 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
Moderate
|
8 Participants
|
15 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
Severe
|
3 Participants
|
6 Participants
|
|
Mayo Clinic Bowel Preparation Questionnaire- Symptom Question 7
Unknown/Did not answer
|
18 Participants
|
10 Participants
|
Adverse Events
MoviPrep
Serious events: 3 serious events
Other events: 104 other events
Deaths: 0 deaths
GoLYTELY
Serious events: 2 serious events
Other events: 121 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MoviPrep
n=202 participants at risk
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 participants at risk
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
1.5%
3/202 • 3 days
|
0.48%
1/210 • 3 days
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/202 • 3 days
|
0.48%
1/210 • 3 days
|
Other adverse events
| Measure |
MoviPrep
n=202 participants at risk
For MoviPrep, the dose, schedule, and route of administration are as follows:
* On the evening prior to the colonoscopy, mix the powder with lukewarm water to a total volume of 32 oz. Drink 8 oz. every 15 minutes until the solution is finished. Drink 16 oz. of clear liquids before bed.
* On the morning of the procedure, repeat the above steps and make sure all fluids are consumed at least 2 hours prior to colonoscopy.
* Limit food intake to a regular breakfast, light lunch and clear soup or plain yogurt for dinner on the day prior to the colonoscopy (completed at least 1 hour prior to the first MoviPrep dose.
* Consume only clear liquids from the start of MoviPrep until after the colonoscopy.
MoviPrep: Split-dose MoviPrep bowel preparation
|
GoLYTELY
n=210 participants at risk
For GoLYTELY, the dose, schedule, and route of administrate are as follows:
* On the evening prior to the colonoscopy, mix powder with lukewarm water to a total volume of 4 liters. Drink 2 liters of the solution and store the rest in the refrigerator.
* Drink the remaining 2 liters on the morning of the procedure.
* Limit food intake to a light breakfast on the day prior to the colonoscopy, followed by only clear liquids until the procedure is complete.
* Avoid red and purple liquids.
Golytely: Split-dose GoLYTELY bowel preparation
|
|---|---|---|
|
Gastrointestinal disorders
Bloating or gas
|
45.5%
92/202 • 3 days
|
51.4%
108/210 • 3 days
|
|
Gastrointestinal disorders
Abdominal pain or cramping
|
30.2%
61/202 • 3 days
|
35.7%
75/210 • 3 days
|
|
Gastrointestinal disorders
Nausea or vomiting
|
25.7%
52/202 • 3 days
|
24.3%
51/210 • 3 days
|
|
Nervous system disorders
Headache
|
14.9%
30/202 • 3 days
|
15.7%
33/210 • 3 days
|
|
Renal and urinary disorders
Hypokalemia
|
5.0%
10/202 • 3 days
|
7.6%
16/210 • 3 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place