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Miralax (PEG 3350) vs. Golytely as Bowel Preparation for Screening Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170754
Recruitment Status : Completed
First Posted : July 27, 2010
Results First Posted : June 14, 2016
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Temple University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Colon Cancer
Interventions Drug: PEG-3350 and Gatorade
Drug: Golytely 4 liters
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description

255 miralax with 64 oz gatorade.

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.
Period Title: Overall Study
Started 66 70
Completed 66 70
Not Completed 0 0
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters Total
Hide Arm/Group Description

255 miralax with 64 oz gatorade.

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.

 Total of all reporting groups
Overall Number of Baseline Participants 66 70 136
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 70 participants 136 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
60
  90.9%
64
  91.4%
124
  91.2%
>=65 years
6
   9.1%
6
   8.6%
12
   8.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 70 participants 136 participants
56.3  (8.4) 56.7  (7.0) 56.4  (7.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 70 participants 136 participants
Female
30
  45.5%
44
  62.9%
74
  54.4%
Male
36
  54.5%
26
  37.1%
62
  45.6%
1.Primary Outcome
Title Boston Prep Scale
Hide Description

The study is a non-inferiority study: The objective is to conclude that the prep quality scores of those receiving Miralax is at most 10% less than for Golytely. Thus the difference in prep scores between Miralax minus Golytely should be greater than - 10%. If this is the case, Miralax would be considered as non-inferior to Golytely.

The outcome measure will use the Boston Prep Scale. The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:

0 = Unprepared colon segment with mucosa not seen due to solid stool.

  1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen.
  2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid
  3. = clear colon without staining
Time Frame photographs were taken throughout the colonoscopy and reviewed within 1 month after procedure.
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all subjects who were enrolled and underwent procedure (Intention-to-treat analysis)
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.0  (2.1) 7.2  (1.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Inferiority between the two groups was defined as a difference of 10% in the overall BBPS score
Statistical Test of Hypothesis P-Value .45
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
2.Secondary Outcome
Title Sodium Level in mmol/L
Hide Description Sodium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mmol/L
138.8  (2.4) 139.3  (2.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .13
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Potassium Level in mmol/L
Hide Description Potassium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mmol/L
4.0  (3.2) 3.9  (3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .31
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Chloride Level in mmol/L
Hide Description Chloride level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mmol/L
104.1  (2.6) 104.2  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .87
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Bicarbonate Level in mmol/L
Hide Description Bicarbonate level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mmol/L
26.4  (2.5) 25.9  (2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .25
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title BUN Level in mg/dl
Hide Description BUN level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mg/dl
9.0  (3.4) 9.5  (4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .47
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title Creatinine Level in mg/dl
Hide Description Creatinine level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mg/dl
0.9  (0.19) 1.1  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .34
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title Glucose Level in mg/dl
Hide Description Glucose level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mg/dl
98.2  (12.2) 93.7  (21.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .18
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
9.Secondary Outcome
Title Calcium Level in mg/dl
Hide Description Calcium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mg/dl
9.3  (0.35) 9.3  (0.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .75
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Magnesium Level in mg/dl
Hide Description Magnesium level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mg/dl
2.1  (0.20) 2.1  (0.26)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .92
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Phosphorus Level in mg/dl
Hide Description Phosphorus level: Risks from the preparation include failure to cleanse the colon adequately and the risk of electrolyte abnormalities, particularly hypokalemia. We will compare adverse events from the comparator preps by assessing electrolytes on the day of the procedure.
Time Frame Day of procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 66 70
Mean (Standard Deviation)
Unit of Measure: mg/dl
3.4  (0.52) 3.5  (0.60)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments Equivalence between the two groups was defined as a p-value = or >.05.
Statistical Test of Hypothesis P-Value .60
Comments p<.05 was defined as the a priori threshold for statistical significance
Method t-test, 2 sided
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Boston Prep Scale (Per Protocol Analysis)
Hide Description

Analysis includes a sub-group of subjects who drank >75% of the preparation and adhered to a clear liquid diet (Per Protocol).

The BPS is scored 0-9 with 9 being an excellent preparation throughout the colon. From the right colon, transverse colon , and left colon a score of 0-3 is given as follows and the total BPS is the arithmetic sum from each colon segment:
Time Frame photographs were taken throughout colonoscopy and reviewed within 1 month after procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Includes subjects who followed instructions (Per Protocol analysis)
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description:

255 miralax with 64 oz gatorade.

PEG-3350 and Gatorade: 255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely 4 liters: Golytely 4 liters
Overall Number of Participants Analyzed 50 54
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.4  (1.8) 7.4  (1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-3350 and Gatorade, Golytely 4 Liters
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Inferiority between groups was defined as a difference of 10% in the overall BBPS score.
Statistical Test of Hypothesis P-Value .98
Comments p<.05 was defined as the a priori threshold for statistical significance.
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Only for the day of the procedure for electrolytes and 24 hours later for symptoms after procedure and complications from colonoscopy.
Adverse Event Reporting Description We checked a basic metabolic profile on day of colonoscopy. All patients called the day after procedure to assess for complications.
 
Arm/Group Title PEG-3350 and Gatorade Golytely 4 Liters
Hide Arm/Group Description

255 miralax with 64 oz gatorade.

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.

Golytely 4 Liters

Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation.
All-Cause Mortality
PEG-3350 and Gatorade Golytely 4 Liters
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
PEG-3350 and Gatorade Golytely 4 Liters
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/66 (0.00%)      0/70 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PEG-3350 and Gatorade Golytely 4 Liters
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/66 (6.06%)      4/70 (5.71%)    
Renal and urinary disorders     
Hypokalemia † 1 [1]  4/66 (6.06%)  4 4/70 (5.71%)  4
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, other
[1]
These adverse events were for potassium levels between 3.0-3.5 meq/ml.
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frank Friedenberg, MD
Organization: Temple University
Phone: 215-707-9900
EMail: frank.friedenberg@temple.edu
Publications of Results:
McKenna T, Macgill A, Porat G, Friedenberg FK. Colonoscopy preparation: polyethylene glycol with Gatorade is as safe and efficacious as four liters of polyethylene glycol with balanced electrolytes. Dig Dis Sci. 2012 Dec;57(12):3098-105. doi: 10.1007/s10620-012-2266-5. Epub 2012 Jun 19.
Layout table for additonal information
Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT01170754    
Other Study ID Numbers: PEG-3350
First Submitted: July 22, 2010
First Posted: July 27, 2010
Results First Submitted: April 16, 2015
Results First Posted: June 14, 2016
Last Update Posted: September 13, 2017