Efficacy of Bowel PreparationNCT01398020
Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation
A study testing Standard Bowel Prep and 2L Bi-Peglyte Bowel Prep in people with Efficacy of Bowel Preparation and Ease of Bowel Preparation and Patient Tolerability, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Efficacy of Bowel Preparation, Ease of Bowel Preparation and Patient Tolerability
- What is being tested?
- Standard Bowel Prep and 2L Bi-Peglyte Bowel Prep
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2011to Sep 2013
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 or older
- Outpatient colonoscopy
Who cannot join
- constipation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial
The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.
- Being tested
- Standard Bowel Prep, 2L Bi-Peglyte Bowel Prep
- Keywords
- Bowel Preparation, Patient comfort, Bi-Peglyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Bowel PrepDrug
Subjects will be asked to take 4L of Peglyte the day prior to procedure.
2L Bi-Peglyte Bowel PrepDrug
Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.
| Study group | Role | What they receive |
|---|---|---|
| Standard bowel prep | Active comparator | Subject will receive standard bowel prep prior to colonoscopy. Receives: Drug: Standard Bowel Prep |
| 2L Bi-Peglyte | Experimental | Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy. Receives: Drug: 2L Bi-Peglyte Bowel Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Boston Bowel Preparation Scale between the two groups
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
Measured: 30 minutes
Secondary outcomes (2)
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups
Measured: 20 hours
Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.
Measured: 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionSep 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Efficacy of Bowel PreparationStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A Enns, MD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398020
- Sponsor's protocol ID
- H11-00688
- Status last verified
- Sep 2013
- First submitted
- 14 Jul 2011
- Last updated
- 19 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial
- ClinicalTrials.gov ID
- NCT01398020
- Acronym / sponsor ID
- H11-00688
- Keywords
- Bowel Preparation, Patient comfort, Bi-Peglyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 20 Jul 2011 (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.
The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard bowel prep | Active comparator | Drug: Standard Bowel PrepSubject will receive standard bowel prep prior to colonoscopy. |
| 2L Bi-Peglyte | Experimental | Drug: 2L Bi-Peglyte Bowel PrepSubjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 19 or older
- Outpatient colonoscopy
Key exclusion criteria (1 listed)
- constipation
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 |
|---|---|---|
| Standard Bowel PrepSubjects will be asked to take 4L of Peglyte the day prior to procedure. | Drug | Standard bowel prep |
| 2L Bi-Peglyte Bowel PrepSubjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure. | Drug | 2L Bi-Peglyte |
Primary outcome
Difference in Boston Bowel Preparation Scale between the two groups
Time frame: 30 minutes
This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
2 secondary outcomes
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
Time frame: 20 hours
Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
Time frame: 20
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 19 Sep 2013.
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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.
Robert A Enns, MD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Bowel Prep and 2L Bi-Peglyte Bowel Prep in people with Efficacy of Bowel Preparation and Ease of Bowel Preparation and Patient Tolerability, run by University of British Columbia at 1 site in Canada.
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 2 inclusion and 1 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 19 Sep 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 Canada. 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?
Difference in Boston Bowel Preparation Scale between the two groups (time frame: 30 minutes). 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 19 Sep 2013.