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A Comparison of 5 Low Volume Bowel Preparations

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier:
NCT01719653
First received: October 28, 2012
Last updated: March 23, 2017
Last verified: March 2017
Results First Received: March 23, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Investigator;   Primary Purpose: Treatment
Condition: Bowel Preparation for Colonoscopy
Interventions: Drug: MiraLAX
Other: Gatorade
Drug: MoviPrep
Drug: SUPREP

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
MiraLAX 306 g (Day-Prior)

MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM

MiraLAX: MiraLAX consumed as described in each arm.

Gatorade: Gatorade consumed as described in each arm.

MiraLAX 357 g (Day-Prior)

MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.

MiraLAX: MiraLAX consumed as described in each arm.

Gatorade: Gatorade consumed as described in each arm.

MiraLAX 306 g (Split-Dose)

MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.

MiraLAX: MiraLAX consumed as described in each arm.

Gatorade: Gatorade consumed as described in each arm.

MoviPrep (Split-Dose)

MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.

MoviPrep: MoviPrep consumed as described in each arm.

SUPREP (Split-Dose)

SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.

SUPREP: SUPREP consumed as described in each arm.


Participant Flow:   Overall Study
    MiraLAX 306 g (Day-Prior)   MiraLAX 357 g (Day-Prior)   MiraLAX 306 g (Split-Dose)   MoviPrep (Split-Dose)   SUPREP (Split-Dose)
STARTED   209   213   218   218   221 
COMPLETED   200   200   200   200   200 
NOT COMPLETED   9   13   18   18   21 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MiraLAX 306 g (Day-Prior)

MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM

MiraLAX: MiraLAX consumed as described in each arm.

Gatorade: Gatorade consumed as described in each arm.

MiraLAX 357 g (Day-Prior)

MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.

MiraLAX: MiraLAX consumed as described in each arm.

Gatorade: Gatorade consumed as described in each arm.

MiraLAX 306 g (Split-Dose)

MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.

MiraLAX: MiraLAX consumed as described in each arm.

Gatorade: Gatorade consumed as described in each arm.

MoviPrep (Split-Dose)

MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.

MoviPrep: MoviPrep consumed as described in each arm.

SUPREP (Split-Dose)

SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.

SUPREP: SUPREP consumed as described in each arm.

Total Total of all reporting groups

Baseline Measures
   MiraLAX 306 g (Day-Prior)   MiraLAX 357 g (Day-Prior)   MiraLAX 306 g (Split-Dose)   MoviPrep (Split-Dose)   SUPREP (Split-Dose)   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   200   200   200   200   1000 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.9  (12.7)   61.3  (12.4)   59.1  (11.3)   60.1  (11.4)   60.6  (11.2)   60.4  (11.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      99  49.5%      99  49.5%      101  50.5%      97  48.5%      99  49.5%      495  49.5% 
Male      101  50.5%      101  50.5%      99  49.5%      103  51.5%      101  50.5%      505  50.5% 
Region of Enrollment 
[Units: Participants]
           
United States   200   200   200   200   200   1000 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Chicago Bowel Preparation Scale   [ Time Frame: At completion of colonoscopy - day 1 ]

2.  Secondary:   Boston Bowel Preparation Scale   [ Time Frame: At completion of colonoscopy - day 1 ]

3.  Secondary:   Adequate/Inadequate Scale   [ Time Frame: At completion of colonoscopy - day 1 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: David Gerard, MD
Organization: Gastroenterology Services, Ltd
phone: 630 969 1167
e-mail: davidpgerard@comcast.net


Publications of Results:

Responsible Party: Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier: NCT01719653     History of Changes
Other Study ID Numbers: 1220121180
Study First Received: October 28, 2012
Results First Received: March 23, 2017
Last Updated: March 23, 2017