Comparing Two Different Ways to Take MoviPrep® Before Colonoscopy

NCT00929916 | Completed

• 1 other identifier: #08C.251
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colonoscopy

Keywords

colonoscopy; MoviPrep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Study Officials

• David M Kastenberg, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2009
• First Posted: June 30, 2009
• Study Start: December 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: March 12, 2013

Record last verified: 2013-03

Locations

US (1)