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

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ClinicalTrials.gov Identifier: NCT00953017
Recruitment Status : Completed
First Posted : August 6, 2009
Results First Posted : November 30, 2012
Last Update Posted : November 30, 2012
Sponsor:
Information provided by (Responsible Party):
Joel Z. Stengel, Brooke Army Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Treatment
Condition Colonoscopy
Interventions Drug: Miralax (PEG 3350)
Drug: Amitiza (Lubiprostone)
Drug: Dulcolax (Bisacodyl)
Drug: Golytely (polyethylene glycol)
Enrollment 425
Recruitment Details All pateints were recruited and enrolled at Brooke Army Medical Center in San Antonio, TX from July 1, 2009 to July 1, 2010.
Pre-assignment Details NO significant events occured prior to study participant enrollment.
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Hide Arm/Group Description 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. 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. 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. 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
Period Title: Overall Study
Started 106 107 106 106
Completed 101 101 100 101
Not Completed 5 6 6 5
Reason Not Completed
DId not show up for colonoscopy             4             4             5             4
Incomplete data             1             1             0             0
Procedure incomplete due to pain/looping             0             1             0             1
Brown stool prior to procedure             0             0             1             0
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol) Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 106 107 106 106 425
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 107 participants 106 participants 106 participants 425 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
104
  98.1%
107
 100.0%
106
 100.0%
104
  98.1%
421
  99.1%
>=65 years
2
   1.9%
0
   0.0%
0
   0.0%
2
   1.9%
4
   0.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 107 participants 106 participants 106 participants 425 participants
55.4  (5.7) 53.8  (5.4) 54.1  (5.3) 54.2  (6.7) 54  (5.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 107 participants 106 participants 106 participants 425 participants
Female
55
  51.9%
48
  44.9%
54
  50.9%
49
  46.2%
206
  48.5%
Male
51
  48.1%
59
  55.1%
52
  49.1%
57
  53.8%
219
  51.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 107 participants 106 participants 106 participants 425 participants
106 107 106 106 425
1.Primary Outcome
Title The Cleanliness of the Prep as Measured by the Ottawa Scale
Hide Description 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.
Time Frame measured at the time of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 101 101 100 101
Mean (Full Range)
Unit of Measure: Ottawa Scale
6.3
(4 to 12)
6.8
(4 to 13)
6.9
(4 to 13)
5.1
(3 to 10)
2.Secondary Outcome
Title Patient Satisfaction With the Prep Measured by 5 Point Likert Scale
Hide Description patient satisfaction based on a Likert Scale from 0-5 (5 being completely satisfied and 0 being not satisfied)
Time Frame measured at check in to colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 101 101 100 101
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (1.1) 4.1  (0.8) 4.0  (1.0) 3.2  (1.0)
3.Secondary Outcome
Title Procedure Time
Hide Description total colonoscopy procedure time
Time Frame measured at the time of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 101 101 100 101
Mean (Standard Deviation)
Unit of Measure: minutes
21.3  (10.2) 19.3  (8.1) 20  (9) 18.3  (7.2)
4.Secondary Outcome
Title Polyps Detected
Hide Description Number of polyps
Time Frame measured at the time of colonoscopy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Hide Arm/Group Description:
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.
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.
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.
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 Number of Participants Analyzed 101 101 100 101
Measure Type: Number
Unit of Measure: polyps
128 92 90 101
Time Frame 1 year
Adverse Event Reporting Description Questionnaire was used to identify all 'Other (Not Including Serious) Adverse Events'
 
Arm/Group Title Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Hide Arm/Group Description 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. 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. 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. 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
All-Cause Mortality
Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/101 (0.00%)      0/101 (0.00%)      0/100 (0.00%)      0/101 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Miralax Plus Amitiza Miralax Plus Dulcolax Miralax Golytely (Polyethylene Glycol)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/101 (5.94%)      4/101 (3.96%)      6/100 (6.00%)      7/101 (6.93%)    
Gastrointestinal disorders         
Nausea  [1]  2/101 (1.98%)  2 3/101 (2.97%)  3 6/100 (6.00%)  6 4/101 (3.96%)  4
Abdominal Cramping  [2]  4/101 (3.96%)  4 2/101 (1.98%)  2 2/100 (2.00%)  2 4/101 (3.96%)  4
Abdominal Bloating  [3]  1/101 (0.99%)  1 2/101 (1.98%)  2 2/100 (2.00%)  2 1/101 (0.99%)  1
Indicates events were collected by systematic assessment
[1]
questionnaire used to identify any patient complaints of nausea
[2]
questionnaire used to identify any patient complaints of abdominal cramping
[3]
questionnaire used to identify any patient complaints of abdominal bloating
Indication for colonoscopy was restricted to colorectal cancer screening. Patients admitted to the hospital were not included. Polyp detection rates could have been influenced by unequal randomization of high-risk and low-risk patients for adenomas.
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: Dr. Michael Hjelkrem
Organization: Fort Belvoir Community Hospital
Phone: 531-231-2015
EMail: mhjelkrem@yahoo.com
Layout table for additonal information
Responsible Party: Joel Z. Stengel, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT00953017     History of Changes
Other Study ID Numbers: C.2009.209
First Submitted: August 5, 2009
First Posted: August 6, 2009
Results First Submitted: September 6, 2012
Results First Posted: November 30, 2012
Last Update Posted: November 30, 2012