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A Comparison of 5 Low Volume Bowel Preparations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01719653
First Posted: November 1, 2012
Last Update Posted: March 24, 2017
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.
Information provided by (Responsible Party):
Gastroenterology Services, Ltd.
October 28, 2012
November 1, 2012
March 23, 2017
March 24, 2017
March 24, 2017
October 2012
September 2014   (Final data collection date for primary outcome measure)
Chicago Bowel Preparation Scale [ Time Frame: At completion of colonoscopy - day 1 ]
The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049). Chicago BPS total score is ranges from 0 (very poor) to 36 (outstanding). Modified Chicago BPS total score is ranges from 0 (very poor) to 33 (outstanding). Chicago BPS Fluid score is ranges from 0 (dry) to 3 (wet).
Chicago Bowel Preparation Scale [ Time Frame: At completion of colonoscopy - day 1 ]
The quality of the colon preparation as graded using our new Chicago Bowel Preparation Scale (BPS) (Adventist Midwest Region Institutional Review Board, AMH 2010-01-80; ClinicalTrials.gov NCT01063049).
Complete list of historical versions of study NCT01719653 on ClinicalTrials.gov Archive Site
  • Boston Bowel Preparation Scale [ Time Frame: At completion of colonoscopy - day 1 ]
    The quality of the colon preparation as graded using Boston Bowel Preparation total scores is range from 0 (very poor) to 9 (outstanding).
  • Adequate/Inadequate Scale [ Time Frame: At completion of colonoscopy - day 1 ]
    The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.
  • Boston Bowel Preparation Scale [ Time Frame: At completion of colonoscopy - day 1 ]
    The quality of the colon preparation as graded using Boston Bowel Preparation Scale.
  • Adequate/Inadequate Scale [ Time Frame: At completion of colonoscopy - day 1 ]
    The cleanliness of the colon as rated by the gastroenterologist using an adequate/inadequate scale where an adequate preparation is defined as being able to see at least 95% of the mucosa of the colon after washing and suctioning; otherwise, the preparation is rated as inadequate.
  • Patient tolerance questionnaire [ Time Frame: Immediately before colonoscopy - day 1 ]
    Patient tolerance of each preparation will be measured by a questionnaire filled out by each subject immediately before the colonoscopy.
Not Provided
Not Provided
 
A Comparison of 5 Low Volume Bowel Preparations
A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy
The purpose of this investigation is to compare 3 versions of MiraLAX/Gatorade, MoviPrep and SUPREP to see which preparation cleanses the colon best and which preparation is best tolerated.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Bowel Preparation for Colonoscopy
  • Drug: MiraLAX
    MiraLAX consumed as described in each arm.
    Other Name: PEG-3350
  • Other: Gatorade
    Gatorade consumed as described in each arm.
  • Drug: MoviPrep
    MoviPrep consumed as described in each arm.
  • Drug: SUPREP
    SUPREP consumed as described in each arm.
  • Active Comparator: 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
    Interventions:
    • Drug: MiraLAX
    • Other: Gatorade
  • Experimental: 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.
    Interventions:
    • Drug: MiraLAX
    • Other: Gatorade
  • Experimental: 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.
    Interventions:
    • Drug: MiraLAX
    • Other: Gatorade
  • Active Comparator: 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.
    Intervention: Drug: MoviPrep
  • Active Comparator: 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.
    Intervention: Drug: SUPREP
Gerard DP, Foster DB, Holden JL, Kang J, Raiser MW. Clinical Trial of 1000 Subjects Randomized to 5 Low-Volume Bowel Preparations for Colonoscopy and Their Acceptance of Split-Dose Bowel Preparations. J Clin Gastroenterol. 2017 Jul;51(6):512-521. doi: 10.1097/MCG.0000000000000575.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1079
September 2014
September 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients at least 18 years old planning to undergo an elective colonoscopy will be eligible for inclusion in our study. We would prefer to exclude as few groups as possible since in clinical practice these less well studied groups often need a colonoscopy and will need to have a colonoscopy preparation.

Exclusion Criteria:

  1. Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
  2. Patients who are pregnant.
  3. Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
  4. Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
  5. Patients with known renal disease (baseline creatinine greater than 1.50 mg/dl) will need to be excluded due to the magnesium in SUPREP which is contraindicated in patients with significant renal disease.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01719653
1220121180
Yes
Not Provided
Not Provided
Gastroenterology Services, Ltd.
Gastroenterology Services, Ltd.
Not Provided
Principal Investigator: David Gerard, MD Gastroenterology Services, Ltd.
Gastroenterology Services, Ltd.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP