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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
History of Changes
  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:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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
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 June 17, 2013