Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy

Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.

This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.

Study Overview

• Status: Withdrawn
• Conditions: Patients Undergoing Screening or Surveillance Colonoscopy
• Intervention / Treatment: Drug: PEG+E; Drug: PEG+Asc; Drug: P+MC; Drug: sulfate

Detailed Description

We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include

1. Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
2. Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
3. Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
4. Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital & the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years or greater
2. Ability to understand and complete questionnaires
3. Ability to speak and read English
4. Willingness to participate in study
5. Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes

Exclusion Criteria:

1. Previous bowel resection of any kind (small or large bowel)
2. End stage renal disease (ESRD)
3. Contraindication to bowel purgative
4. Necessity for inpatient admission to receive bowel preparation for any reason
5. Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
6. Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
7. Subject did not follow appropriate dosing instructions for bowel purgative
8. Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
9. History of colon polyposis syndrome
10. Personal history of inflammatory bowel disease
11. History of inadequate colon preparation on any prior colonoscopies
12. Patient is pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: PEG+E; Split dose 4 liter polyethylene glycol with electrolytes	Drug: PEG+E; Split dose 4 liter polyethylene glycol with electrolytes; Other Names: Golytely
ACTIVE_COMPARATOR: PEG+Asc; Split dose 2 liter polyethylene glycol with ascorbic acid	Drug: PEG+Asc; Split dose 2 liter polyethylene glycol with ascorbic acid; Other Names: MoviPrep
ACTIVE_COMPARATOR: P+MC; Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid	Drug: P+MC; Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid; Other Names: Suprep
ACTIVE_COMPARATOR: sulfate; Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution	Drug: sulfate; Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution; Other Names: Prepopik

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)	Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient tolerability and satisfaction	Will be assessed using a previously studied satisfaction questionnaire (7 items)	Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ANTICIPATED): August 1, 2014
• Study Completion (ANTICIPATED): June 1, 2015

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (ESTIMATE): April 28, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): July 10, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: PRO00022505