Comparing Two Different Ways to Take MoviPrep® Before Colonoscopy

Efficacy of a Low Volume PEG Purgative (MoviPrep®) Administered Entirely in the Morning Compared to Split Dose (PM/AM) Administration

This study will evaluate whether morning-only dosing of MoviPrep® (2L) for afternoon colonoscopy is as effective as a standard dosing regimen of half of the volume of MoviPrep® (1L) solution the evening prior, and half (1L) the morning of, colonoscopy. MoviPrep® is a low volume (2 liters) polyethylene glycol (PEG)-based purgative that is approved for evening-only or split (evening and morning) dosing to cleanse the colon prior to colonoscopy. Patients undergoing afternoon colonoscopies often have inferior colon cleansing. There is evidence that morning-only purgative administration of large volume PEG (4L) is safe and effective. This study will assess whether administration of a low volume PEG regimen will maintain efficacy and improve tolerance by changing a 2-day preparation procedure into a regimen that is completed in 1 day.

Study Overview

• Status: Completed
• Conditions: Colonoscopy

Detailed Description

primary objectives

• To compare the efficacy of morning dose only MoviPrep® ("AM Dosing") where one-half of the prep is given 7 hours before colonoscopy and the second half is given 4 hours before colonoscopy, versus split dose (PM/AM) MoviPrep® ("PM/AM Dosing") where one-half of the prep is given at 6pm the night prior to colonoscopy and the second half is given 4 hours before colonoscopy.

Efficacy will be assessed based on cleansing of the entire colon, with successful cleansing defined as a score of excellent or good and unsuccessful cleansing defined as a score of fair or poor.

Secondary objectives

• To assess the tolerability of AM Dosing MoviPrep® versus PM/AM Dosing MoviPrep® based on percentage of prep completed, sleep quality/quantity, future prep choice (same prep or alternative prep described), and incidence and severity (using 11-point Likert scale) of any adverse events (i.e. nausea, vomiting, abdominal pain, bloating, light-headedness).
• To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy.
• To evaluate the effect of colon prep on work and productivity as measured by the degree of interference with work/productivity the day prior to colonoscopy.
• To assess difference between two dosing arms with respect to analysis of right colon cleansing, and overall adenoma detection in terms of number, size, location, histology, and morphology.
• To determine the effect of purgative dosing on procedure efficiency by measuring (a) total procedure time, (b) time from anus to cecum, and (c) withdrawal time (excluding time taken for interventions).
• To evaluate the effect of purgative dosing regimen on amount of flushing required during the procedure (0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml).
• To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

out-patients scheduled for afternoon colonoscopy in the Thomas Jefferson GI group

Description

Inclusion Criteria:

• Elective out-patients scheduled for afternoon colonoscopy (12 pm or later).

Exclusion Criteria:

• Unable or unwilling to consent
• Age < 18 years
• Pregnant
• Breast feeding
• Gastroparesis - known or suspected
• Chronic nausea or vomiting
• Bowel obstruction
• Hypomotility syndrome: pseudo-obstruction, megacolon, etc.
• Severe constipation (< 1 BM a week)
• Greater than 50% resection of colon
• Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency
• PEG allergy
• Significant psychiatric illness

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
AM dosing of MoviPrep®; Take prep morning of exam
PM/AM dosing of MoviPrep®; half of the volume of prep(1L) solution the evening prior, and half (1L) the morning of, colonoscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparing the efficacy of AM dose only MoviPrep® (1/2 the prep 7 hrs pre colonoscopy and the second 1/2 4 hrs pre colonoscopy), versus PM/AM where 1/2 of the prep is at 6pm the night prior to colonoscopy and the second half is 4 hours before colonoscopy.	once

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the tolerability of AM Dosing MoviPrep® versus PM/AM Dosing MoviPrep® based on % of prep completed, sleep quality/quantity, future prep choice (same prep or alternative prep described), and incidence and severity of any adverse events	once
To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy	once
To evaluate the effect of colon prep on work and productivity as measured by the degree of interference with work/productivity the day prior to colonoscopy.	once
To assess difference between two dosing arms with respect to analysis of right colon cleansing, and overall adenoma detection in terms of number, size, location, histology, and morphology.	once
To determine the effect of purgative dosing on procedure efficiency by measuring (a) total procedure time, (b) time from anus to cecum, and (c) withdrawal time (excluding time taken for interventions).	once
To evaluate the effect of purgative dosing regimen on amount of flushing required during the procedure (0 = none, 1 = <50 ml, 2 = 50-100 ml, 3 = >100 ml).	once
To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.	once

Collaborators and Investigators

• Sponsor: Thomas Jefferson University
• Collaborators: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: David M Kastenberg, MD, Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: June 29, 2009
• First Submitted That Met QC Criteria: June 29, 2009
• First Posted (Estimate): June 30, 2009

Study Record Updates

• Last Update Posted (Estimate): March 12, 2013
• Last Update Submitted That Met QC Criteria: March 11, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Keywords: colonoscopy; MoviPrep
• Other Study ID Numbers: #08C.251