Patients Undergoing Screening or Surveillance ColonoscopyNCT02124447
Single Center Comparison of 4 FDA Approved, Commercially Available Bowel Purgatives for Colonoscopy
A study testing PEG+E, PEG+Asc and P+MC in people with Patients Undergoing Screening or Surveillance Colonoscopy, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients Undergoing Screening or Surveillance Colonoscopy
- What is being tested?
- PEG+E, PEG+Asc and P+MC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Jun 2015
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or greater
- Ability to understand and complete questionnaires
- Ability to speak and read English
- Willingness to participate in study
- Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes
Who cannot join
- Previous bowel resection of any kind (small or large bowel)
- End stage renal disease (ESRD)
- Contraindication to bowel purgative
- Necessity for inpatient admission to receive bowel preparation for any reason
- Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
- Currently taking stool softeners (e.g. Miralax, Amitiza, Linzess, lactulose) or stimulant laxatives (e.g. Dulcolax)
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- Subject did not follow appropriate dosing instructions for bowel purgative
- Colonoscopy is being performed to evaluate a clinical symptom such as rectal bleeding, constipation, abdominal pain, or diarrhea
- History of colon polyposis syndrome
- Personal history of inflammatory bowel disease
- History of inadequate colon preparation on any prior colonoscopies
- Patient is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Froedtert Hospital & The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
This will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.
Read the detailed description
We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include
- Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
- Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
- Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
- Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep
- Being tested
- PEG+E, PEG+Asc, P+MC, sulfate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG+EDrug
Also called Golytely
Split dose 4 liter polyethylene glycol with electrolytes
PEG+AscDrug
Also called MoviPrep
Split dose 2 liter polyethylene glycol with ascorbic acid
P+MCDrug
Also called Suprep
Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
sulfateDrug
Also called Prepopik
Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
| Study group | Role | What they receive |
|---|---|---|
| PEG+E | Active comparator | Split dose 4 liter polyethylene glycol with electrolytes Receives: Drug: PEG+E |
| PEG+Asc | Active comparator | Split dose 2 liter polyethylene glycol with ascorbic acid Receives: Drug: PEG+Asc |
| P+MC | Active comparator | Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid Receives: Drug: P+MC |
| sulfate | Active comparator | Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution Receives: Drug: sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
Measured: Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure
Secondary outcomes (1)
Patient tolerability and satisfaction
Will be assessed using a previously studied satisfaction questionnaire (7 items)
Measured: Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2014 (estimated)
- Study completionJun 2015 (estimated)
Why it stopped: Protocol issues. Modifications potentially will be undertaken and resubmitted to IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing Screening or Surveillance ColonoscopyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zachary Smith, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124447
- Sponsor's protocol ID
- PRO00022505
- Status last verified
- Jul 2015
- First submitted
- 23 Apr 2014
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Patient Tolerability of Four Commercially Available Bowel Purgatives for Screening and Surveillance Colonoscopy: A Single Tertiary Medical Center Experience.
- ClinicalTrials.gov ID
- NCT02124447
- Acronym / sponsor ID
- PRO00022505
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol issues. Modifications potentially will be undertaken and resubmitted to IRB
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 28 Apr 2014 (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 will be a 4-way comparison to prospectively evaluate the efficacy and patient tolerability of four commercially available bowel preparations among patients undergoing colonoscopy for screening and surveillance in a single tertiary academic medical center.
Detailed description
We will randomize 300 consecutive patients undergoing colonoscopy for screening or surveillance purposes to receive one of four bowel purgatives. These purgatives include
- Split dose 4 liter polyethylene glycol with electrolytes (PEG+E): Brand name GoLytely
- Split dose 2 liter polyethylene glycol with ascorbic acid (PEG+Asc): Brand name: MoviPrep
- Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid (P+MC): Brand name Prepopik
- Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution (sulfate): Brand name Suprep
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PEG+E | Active comparator | Drug: PEG+ESplit dose 4 liter polyethylene glycol with electrolytes |
| PEG+Asc | Active comparator | Drug: PEG+AscSplit dose 2 liter polyethylene glycol with ascorbic acid |
| P+MC | Active comparator | Drug: P+MCSplit dose sodium picosulfate, magnesium oxide, and anhydrous citric acid |
| sulfate | Active comparator | Drug: sulfateSplit dose sodium sulfate, magnesium sulfate, and potassium sulfate solution |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 years or greater
- Ability to understand and complete questionnaires
- Ability to speak and read English
- Willingness to participate in study
- Colonoscopy is being performed for routine screening (i.e. no prior personal history of polyps or cancer) or surveillance (i.e. follow up for a personal history of polyps) purposes
Key exclusion criteria (12 listed)
- Previous bowel resection of any kind (small or large bowel)
- End stage renal disease (ESRD)
- Contraindication to bowel purgative
- Necessity for inpatient admission to receive bowel preparation for any reason
- Currently taking any narcotic/opiate pain or anticholinergic medication (since these may predispose to higher colon stool burden at baseline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEG+EAlso: GolytelySplit dose 4 liter polyethylene glycol with electrolytes | Drug | PEG+E |
| PEG+AscAlso: MoviPrepSplit dose 2 liter polyethylene glycol with ascorbic acid | Drug | PEG+Asc |
| P+MCAlso: SuprepSplit dose sodium picosulfate, magnesium oxide, and anhydrous citric acid | Drug | P+MC |
| sulfateAlso: PrepopikSplit dose sodium sulfate, magnesium sulfate, and potassium sulfate solution | Drug | sulfate |
Primary outcome
Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS)
Time frame: Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure
1 secondary outcome
Patient tolerability and satisfaction
Time frame: Outcome of satisfaction will be assessed on a single survey that the patient will provide the day of their colonoscopy and will be recorded by study personnel up to 30 days thereafter
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEG+E, PEG+Asc and P+MC in people with Patients Undergoing Screening or Surveillance Colonoscopy, run by Medical College of Wisconsin 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 5 inclusion and 12 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: withdrawn, as of the sponsor's last update on 10 Jul 2015. 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of bowel cleansing according to the Boston Bowel Preparation Score (BPPS) (time frame: Patient outcome will be assessed at the time of the colonoscopy by the performing physician and ducomentation of this outcome will occur within 24 hours of the procedure). 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 10 Jul 2015.