ColonoscopyNCT00929916
Comparing Two Different Ways to Take MoviPrep® Before Colonoscopy
An observational study of Colonoscopy, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Apr 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: out-patients scheduled for afternoon colonoscopy in the Thomas Jefferson GI group
Who may be able to join
- Elective out-patients scheduled for afternoon colonoscopy (12 pm or later).
Who cannot join
- Unable or unwilling to consent
- Age < 18 years
- Pregnant
- Breast feeding
- Gastroparesis - known or suspected
- Chronic nausea or vomiting
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
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.
Read the 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.
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, MoviPrep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: once
To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: once
To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColonoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- David M Kastenberg, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929916
- Sponsor's protocol ID
- #08C.251
- Status last verified
- Mar 2013
- First submitted
- 29 Jun 2009
- Last updated
- 12 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Low Volume PEG Purgative (MoviPrep®) Administered Entirely in the Morning Compared to Split Dose (PM/AM) Administration
- ClinicalTrials.gov ID
- NCT00929916
- Acronym / sponsor ID
- #08C.251
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, MoviPrep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- Dec 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- out-patients scheduled for afternoon colonoscopy in the Thomas Jefferson GI group
Key inclusion criteria (1 listed)
- Elective out-patients scheduled for afternoon colonoscopy (12 pm or later).
Key exclusion criteria (13 listed)
- Unable or unwilling to consent
- Age < 18 years
- Pregnant
- Breast feeding
- Gastroparesis - known or suspected
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
To evaluate the safety of each dosing administration based on vitals with orthostatic measures (BP, pulse) on day of colonoscopy
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: once
To validate a new grading scale for colon cleansing using the de-identified recordings of colonoscopies performed during this study.
Time frame: once
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2013.
Related trials for Colonoscopy
Enrolling by invitation
Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection
Colon Polyp, Adenoma
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
Active, not recruiting
IMProving Adherence to Colonoscopy Through Teams and Technology
Colon Cancer, Cancer Colorectal
Not yet recruiting
Enhanced Ward Rounds for Bowel Preparation Quality in Hospitalized Patients Undergoing Colonoscopy
Colonoscopy, Bowel Preparation
Active, not recruiting
Application of Remimazolam Combined With Esketamine in Painless Gastroscopy and Colonoscopy in Elderly Patients
Gastrointestinal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David M Kastenberg, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonoscopy, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.