Comparing Two Different Ways to Take MoviPrep® Before Colonoscopy

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00929916
First received: June 29, 2009
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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.


Condition
Colonoscopy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of a Low Volume PEG Purgative (MoviPrep®) Administered Entirely in the Morning Compared to Split Dose (PM/AM) Administration

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • 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. [ Time Frame: once ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: once ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy [ Time Frame: once ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: once ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: once ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: once ] [ Designated as safety issue: No ]
  • 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). [ Time Frame: once ] [ Designated as safety issue: No ]
  • To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study. [ Time Frame: once ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: December 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  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: NCT00929916

Locations
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Salix Pharmaceuticals
Investigators
Principal Investigator: David M Kastenberg, MD Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00929916     History of Changes
Other Study ID Numbers: #08C.251
Study First Received: June 29, 2009
Last Updated: March 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
colonoscopy
MoviPrep

ClinicalTrials.gov processed this record on October 23, 2014