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
  Purpose

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.


Condition Intervention Phase
Bowel Preparation for Colonoscopy
Drug: MiraLAX
Other: Gatorade
Drug: MoviPrep
Drug: SUPREP
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Five Low Volume Bowel Preparations for Colonoscopy

Resource links provided by NLM:


Further study details as provided by Gastroenterology Services, Ltd.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 1000
Study Start Date: October 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: MiraLAX
MiraLAX consumed as described in each arm.
Other Name: PEG-3350
Other: Gatorade
Gatorade consumed as described in each arm.
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.
Drug: MiraLAX
MiraLAX consumed as described in each arm.
Other Name: PEG-3350
Other: Gatorade
Gatorade consumed as described in each arm.
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.
Drug: MiraLAX
MiraLAX consumed as described in each arm.
Other Name: PEG-3350
Other: Gatorade
Gatorade consumed as described in each arm.
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.
Drug: MoviPrep
MoviPrep consumed as described in each arm.
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.
Drug: SUPREP
SUPREP consumed as described in each arm.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719653

Contacts
Contact: David Gerard, MD 630 969-1167 DavidPGerard@comcast.net
Contact: Diane Foster, PA-c 630 969-1167 GIServices@comcast.net

Locations
United States, Illinois
Gastroenterology Services Recruiting
Downers Grove, Illinois, United States, 60515
Contact: David Gerard, MD    630-969-1167    DavidPGerard@comcast.net   
Sub-Investigator: Manfred Raiser, MD         
Sub-Investigator: John Holden, MD         
Sub-Investigator: Diane Foster, PA-c         
Sponsors and Collaborators
Gastroenterology Services, Ltd.
Investigators
Principal Investigator: David Gerard, MD Gastroenterology Services, Ltd.
  More Information

No publications provided

Responsible Party: Gastroenterology Services, Ltd.
ClinicalTrials.gov Identifier: NCT01719653     History of Changes
Other Study ID Numbers: 1220121180
Study First Received: October 28, 2012
Last Updated: August 20, 2013
Health Authority: United States: Food and Drug Administration
United States: Adventist Midwest Region Institutional Review Board

Keywords provided by Gastroenterology Services, Ltd.:
Colonoscopy
Bowel Preparation
MiraLAX
Gatorade
PEG-3350
MoviPrep
SUPREP
Chicago Bowel Preparation Scale
Boston Bowel Preparation Scale

ClinicalTrials.gov processed this record on July 28, 2014