Comparing Two Different Ways to Take MoviPrep® Before Colonoscopy

Official Title: “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.

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.

Arms, Groups and Cohorts in this Clinical Trial

• : 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.

Primary 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
    Safety Issue?: No

Secondary 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
    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
    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
    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
    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
    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
    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
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Thomas Jefferson University Other

Overall Clinical Trial Officials and Contacts

David M Kastenberg, MD Principal Investigator Thomas Jefferson University  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00929916

Study ID Number: #08C.251

ClinicalTrials.gov Identifier: NCT00929916

Health Authority: United States: Institutional Review Board