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

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ClinicalTrials.gov Identifier: NCT01063049
Recruitment Status : Completed
First Posted : February 5, 2010
Results First Posted : November 18, 2013
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
David Gerard, M.D., Gastroenterology Services, Ltd.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Preparation for Colonoscopy
Interventions Drug: Gatorade/Miralax
Drug: NuLytely
Drug: Bisacodyl
Drug: Placebo
Enrollment 600
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.
Pre-assignment Details  
Arm/Group Title Nulytely Gatorade/Miralax + Placebo Gatorade/Miralax + Bisacodyl
Hide 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
Arm/Group Title Nulytely Gatorade/Miralax + Placebo Gatorade/Miralax + Bisacodyl Total
Hide 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 Number of Baseline Participants 200 200 200 600
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 200 participants 600 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
120
  60.0%
120
  60.0%
120
  60.0%
360
  60.0%
>=65 years
80
  40.0%
80
  40.0%
80
  40.0%
240
  40.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 200 participants 200 participants 200 participants 600 participants
60.2  (13.2) 59.7  (13.8) 61.3  (12.5) 60.4  (13.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants 200 participants 200 participants 600 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  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 200 participants 200 participants 200 participants 600 participants
200 200 200 600
1.Primary Outcome
Title The Quality of the Colon Preparation Will be Graded Using the Boston Bowel Preparation Scale
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nulytely Gatorade/Miralax + Placebo Gatorade/Miralax + Bisacodyl
Hide 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.
Overall Number of Participants Analyzed 200 200 200
Mean (Standard Deviation)
Unit of Measure: 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
Hide Description Ottawa scale measures colon cleanliness on a scale from 14 (very poor) to 0 (excellent).
Time Frame After Colonoscopy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nulytely Gatorade/Miralax + Placebo Gatorade/Miralax + Bisacodyl
Hide 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.
Overall Number of Participants Analyzed 200 200 200
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.80  (2.24) 2.58  (2.47) 2.71  (2.47)
Time Frame up to 1 month after colonoscopy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Nulytely Gatorade/Miralax + Placebo Gatorade/Miralax + Bisacodyl
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide 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 (0.00%)      1/200 (0.50%)      0/200 (0.00%)    
Gastrointestinal disorders       
post-polypectomy bleed *  0/200 (0.00%)  0 1/200 (0.50%)  1 0/200 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.5%
Nulytely Gatorade/Miralax + Placebo Gatorade/Miralax + Bisacodyl
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/200 (0.00%)      0/200 (0.00%)      0/200 (0.00%)    
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. David Gerard
Organization: Gastroenterology Services
Phone: 630 969 1167
Responsible Party: David Gerard, M.D., Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier: NCT01063049     History of Changes
Other Study ID Numbers: 1220100180
First Submitted: February 3, 2010
First Posted: February 5, 2010
Results First Submitted: August 20, 2013
Results First Posted: November 18, 2013
Last Update Posted: November 18, 2013