A Comparison of 5 Low Volume Bowel Preparations

NCT01719653 | Completed Phase 4 Results DMC

• 1 other identifier: 1220121180
• Study Type: interventional
• Target: 1,079
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bowel Preparation for Colonoscopy

Keywords

Colonoscopy; Bowel Preparation; MiraLAX; Gatorade; PEG-3350; MoviPrep; SUPREP; Chicago Bowel Preparation Scale; Boston Bowel Preparation Scale

Outcome Measures

Primary Outcomes (1)

• Chicago Bowel Preparation Scale

  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).

  At completion of colonoscopy - day 1

Secondary Outcomes (2)

• Boston Bowel Preparation Scale

  At completion of colonoscopy - day 1

• Adequate/Inadequate Scale

  At completion of colonoscopy - day 1

Study Arms (5)

MiraLAX 306 g (Day-Prior)

ACTIVE COMPARATOR

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; Other: Gatorade

MiraLAX 357 g (Day-Prior)

EXPERIMENTAL

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; Other: Gatorade

MiraLAX 306 g (Split-Dose)

EXPERIMENTAL

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; Other: Gatorade

MoviPrep (Split-Dose)

ACTIVE COMPARATOR

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

SUPREP (Split-Dose)

ACTIVE COMPARATOR

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

Interventions

MiraLAX DRUG

MiraLAX consumed as described in each arm.

Also known as: PEG-3350

MiraLAX 306 g (Day-Prior); MiraLAX 306 g (Split-Dose); MiraLAX 357 g (Day-Prior)

Gatorade OTHER

Gatorade consumed as described in each arm.

MiraLAX 306 g (Day-Prior); MiraLAX 306 g (Split-Dose); MiraLAX 357 g (Day-Prior)

MoviPrep DRUG

MoviPrep consumed as described in each arm.

MoviPrep (Split-Dose)

SUPREP DRUG

SUPREP consumed as described in each arm.

SUPREP (Split-Dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients who are allergic (this is very rare) or intolerant to any of the study drugs.
• Patients who are pregnant.
• Patients who required multiple day colon preparations (2 days prior and 1 day prior) in the past will be excluded.
• Patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon would not be considered elective colonoscopies and are excluded.
• 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.

Sponsors & Collaborators

• Gastroenterology Services, Ltd.: lead

Study Sites (1)

Gastroenterology Services

Downers Grove, Illinois, 60515, United States

Location

Related Publications (1)

• 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.

  PMID: 27433812 RESULT

MeSH Terms

Interventions

polyethylene glycol 3350; gatorade; MoviPrep

Results Point of Contact

• Title: David Gerard, MD
• Organization: Gastroenterology Services, Ltd

davidpgerard@comcast.net

630 969 1167

Study Officials

• David Gerard, MD

  Gastroenterology Services, Ltd.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2012
• First Posted: November 1, 2012
• Study Start: October 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 24, 2017
• Results First Posted: March 24, 2017

Record last verified: 2017-03

Locations

US (1)