A Comparison of 5 Low Volume Bowel Preparations

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Gastroenterology Services, Ltd.
Sponsor:
Information provided by (Responsible Party):
Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier:
NCT01719653
First received: October 28, 2012
Last updated: August 20, 2013
Last verified: August 2013

October 28, 2012
August 20, 2013
October 2012
April 2014   (final data collection date for primary outcome measure)
Chicago Bowel Preparation Scale [ Time Frame: At completion of colonoscopy - day 1 ] [ Designated as safety issue: No ]
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).
Same as current
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 ] [ Designated as safety issue: No ]
    The quality of the colon preparation as graded using Boston Bowel Preparation Scale.
  • Adequate/inadequate scale [ Time Frame: At completion of colonoscopy - day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Patient tolerance of each preparation will be measured by a questionnaire filled out by each subject immediately before the colonoscopy.
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
Not Provided
April 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.
Both
18 Years and older
Yes
Contact: David Gerard, MD 630 969-1167 DavidPGerard@comcast.net
Contact: Diane Foster, PA-c 630 969-1167 GIServices@comcast.net
United States
 
NCT01719653
1220121180
Yes
Gastroenterology Services, Ltd.
Gastroenterology Services, Ltd.
Not Provided
Principal Investigator: David Gerard, MD Gastroenterology Services, Ltd.
Gastroenterology Services, Ltd.
August 2013

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