ColonoscopyPhase 4NCT01865916
2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation
A Phase 4 study testing Polyethylene Glycol (PEG) and 15 mg Bisacodyl and Polyethylene Glycol (PEG) + ascorbic acid in people with Colonoscopy, run by University of British Columbia at 1 site in Canada.
Trial summary
This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority trial. The purpose of our study is to determine if using a 2-litre mixture in combination with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Polyethylene Glycol (PEG) and 15 mg Bisacodyl and Polyethylene Glycol (PEG) + ascorbic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Feb 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All adults (≥ 19 years of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study.
Who cannot join
- those with constipation,
- suspected or known small bowel obstruction,
- severe inflammatory bowel disease, and
- any history of colonic resection.
Trial locations and contacts
1 site in 1 country.
Canada1 site
GI Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 2K5
About this study
Official title: 2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial
This study is a randomized, controlled, single centre, endoscopist-blinded non-inferiority trial. The purpose of our study is to determine if using a 2-litre mixture in combination with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre PegLyte based preparations with an added laxative agent are commonly used for colonoscopies in outpatient settings. If the investigators discover that a 2-litre mixture with either the tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able to experience fewer side effects and be less troubled by the preparation while still allowing a good view of the colon.
Read the detailed description
All adults (≥ 19 yrs of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study. Exclusion criteria included those with constipation, suspected or known small bowel obstruction, severe inflammatory bowel disease, and any history of colonic resection. 278 consecutive eligible patients will be randomized to one of two bowel preparations through the use of concealed allocation by a scheduling assistant (blinded) in a one-to-one allocation ratio. Bowel preparations included: (i) 2 L of MoviPrep (2 L PEG 3350 electrolyte solution + ascorbic acid) or (ii) Bi-Peglyte (2 L PEG 3350 electrolyte solution and 15mg bisacodyl). Patients in both arms will be instructed to adhere to a clear liquid diet commensing 24 hours prior to scheduled colonoscopy in addition to their remaining bowel preparation.
The investigators will not have access to the randomization envelopes and the randomized bowel preparation will be stored within the medical record that will not be accessible by the endoscopist. The endoscopists can break blinding and access the bowel prep given when medically necessary.
At the time of their procedure check-in, written consent will be confirmed and patients will respond to a brief survey assessing patient tolerance. All colonoscopies will be performed under conscious sedation by an experienced endoscopist. Endoscopists will be blinded to the bowel preparation until the completion of the study. We will use the Boston Bowel Preparation Scale (BBPS) and Ottawa Bowel Preparation Scale (OBPS) to assess efficacy in bowel preparation.
- Conditions
- Colonoscopy
- Being tested
- Polyethylene Glycol (PEG) and 15 mg Bisacodyl, Polyethylene Glycol (PEG) + ascorbic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol (PEG) and 15 mg BisacodylDrug
Also called Bi-Peglyte
Subjects will be asked to take split dose of 2L PEG and 3 tablets of 5 mg Bisacodyl
Polyethylene Glycol (PEG) + ascorbic acidDrug
Also called Moviprep
Subjects will be asked to take split dose of 2L PEG and vitamin C
| Study group | Role | What they receive |
|---|---|---|
| 2 Liters Bi-Peglyte | Active comparator | Subjects will be asked to take split dose of 2 Liters PEG + 15mg bisacodyl for bowel preparation the day before colonoscopy. Receives: Drug: Polyethylene Glycol (PEG) and 15 mg Bisacodyl |
| 2 Liters Moviprep | Experimental | Subject will be asked to take split dose of 2 Liters PEG + ascorbic acid for bowel preparation the day before colonoscopy Receives: Drug: Polyethylene Glycol (PEG) + ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel cleansing efficacy as rated by a Boston Bowel Preparation Scale score of greater than 8
The BBPS is a relatively new, validated scoring system assessing cleanliness of three segments of the colon (left colon, transverse, and right colon). The total is a 10 point scale (0-9) that grades each segment of the colon from 0-3. A segment score of 0 describes: 'unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared'. Segment score 1: 'portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and/or opaque liquid'. Segment score 2: 'minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well'. Segment score 3: 'entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid'. In this study, we define an excellent equivalent BBPS score as 8 or 9. Scores of 7 or above are generally felt to provide a good visualization of the colon.
Measured: 20 hours
Secondary outcomes (1)
Patient tolerability to each 2L product
Our secondary outcome is patient tolerability to each 2L product based on a ten-question survey. The questionnaire basically asks about patient experience in terms of charateristic taste of bowel prep, volume intake, any distressing signs and symptoms, compliance to bowel preparation solution assigned to subjects using a Likert scale. The number of participants in each level will subsequently be quantified (n,%) and compared between the two groups
Measured: 20 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ColonoscopyStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 309 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Enns, MD, FRCP, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01865916
- Sponsor's protocol ID
- H13-00502
- Status last verified
- Jun 2016
- First submitted
- 13 May 2013
- Last updated
- 20 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Beck DE, Harford FJ, DiPalma JA. Comparison of cleansing methods in preparation for colonic surgery. Dis Colon Rectum. 1985 Jul;28(7):491-5. doi: 10.1007/BF02554091.
PubMed 4017808American Society of Colon and Rectal Surgeons (ASCRS); American Society for Gastrointestinal Endoscopy (ASGE); Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc. 2006 Jul;20(7):1147-60. doi: 10.1007/s00464-006-0152-y. Epub 2006 Jun 8. No abstract available.
PubMed 16763922Hsu CW, Imperiale TF. Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation. Gastrointest Endosc. 1998 Sep;48(3):276-82. doi: 10.1016/s0016-5107(98)70191-9.
PubMed 9744604Curran MP, Plosker GL. Oral sodium phosphate solution: a review of its use as a colorectal cleanser. Drugs. 2004;64(15):1697-714. doi: 10.2165/00003495-200464150-00009.
PubMed 15257632Vanner SJ, MacDonald PH, Paterson WG, Prentice RS, Da Costa LR, Beck IT. A randomized prospective trial comparing oral sodium phosphate with standard polyethylene glycol-based lavage solution (Golytely) in the preparation of patients for colonoscopy. Am J Gastroenterol. 1990 Apr;85(4):422-7.
PubMed 2183591Frommer D. Cleansing ability and tolerance of three bowel preparations for colonoscopy. Dis Colon Rectum. 1997 Jan;40(1):100-4. doi: 10.1007/BF02055690.
PubMed 9102248Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.
PubMed 7380204
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial
- ClinicalTrials.gov ID
- NCT01865916
- Acronym / sponsor ID
- H13-00502
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 309 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 31 May 2013 (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 is a randomized, controlled, single centre, endoscopist-blinded non-inferiority trial. The purpose of our study is to determine if using a 2-litre mixture in combination with vitamin C is better than using 2 litres of mixture with bisacodyl tablets. Two-litre PegLyte based preparations with an added laxative agent are commonly used for colonoscopies in outpatient settings. If the investigators discover that a 2-litre mixture with either the tablets or the ascorbic acid work better, future patients undergoing colonoscopy will be able to experience fewer side effects and be less troubled by the preparation while still allowing a good view of the colon.
Detailed description
All adults (≥ 19 yrs of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study. Exclusion criteria included those with constipation, suspected or known small bowel obstruction, severe inflammatory bowel disease, and any history of colonic resection. 278 consecutive eligible patients will be randomized to one of two bowel preparations through the use of concealed allocation by a scheduling assistant (blinded) in a one-to-one allocation ratio. Bowel preparations included: (i) 2 L of MoviPrep (2 L PEG 3350 electrolyte solution + ascorbic acid) or (ii) Bi-Peglyte (2 L PEG 3350 electrolyte solution and 15mg bisacodyl). Patients in both arms will be instructed to adhere to a clear liquid diet commensing 24 hours prior to scheduled colonoscopy in addition to their remaining bowel preparation.
The investigators will not have access to the randomization envelopes and the randomized bowel preparation will be stored within the medical record that will not be accessible by the endoscopist. The endoscopists can break blinding and access the bowel prep given when medically necessary.
At the time of their procedure check-in, written consent will be confirmed and patients will respond to a brief survey assessing patient tolerance. All colonoscopies will be performed under conscious sedation by an experienced endoscopist. Endoscopists will be blinded to the bowel preparation until the completion of the study. We will use the Boston Bowel Preparation Scale (BBPS) and Ottawa Bowel Preparation Scale (OBPS) to assess efficacy in bowel preparation.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 Liters Bi-Peglyte | Active comparator | Drug: Polyethylene Glycol (PEG) and 15 mg BisacodylSubjects will be asked to take split dose of 2 Liters PEG + 15mg bisacodyl for bowel preparation the day before colonoscopy. |
| 2 Liters Moviprep | Experimental | Drug: Polyethylene Glycol (PEG) + ascorbic acidSubject will be asked to take split dose of 2 Liters PEG + ascorbic acid for bowel preparation the day before colonoscopy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults (≥ 19 years of age) who are referred to St. Paul's Hospital for outpatient colonoscopy will be included in our study.
Key exclusion criteria (4 listed)
- those with constipation,
- suspected or known small bowel obstruction,
- severe inflammatory bowel disease, and
- any history of colonic resection.
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 |
|---|---|---|
| Polyethylene Glycol (PEG) and 15 mg BisacodylAlso: Bi-PeglyteSubjects will be asked to take split dose of 2L PEG and 3 tablets of 5 mg Bisacodyl | Drug | 2 Liters Bi-Peglyte |
| Polyethylene Glycol (PEG) + ascorbic acidAlso: MoviprepSubjects will be asked to take split dose of 2L PEG and vitamin C | Drug | 2 Liters Moviprep |
Primary outcome
Bowel cleansing efficacy as rated by a Boston Bowel Preparation Scale score of greater than 8
Time frame: 20 hours
The BBPS is a relatively new, validated scoring system assessing cleanliness of three segments of the colon (left colon, transverse, and right colon). The total is a 10 point scale (0-9) that grades each segment of the colon from 0-3. A segment score of 0 describes: 'unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared'. Segment score 1: 'portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and/or opaque liquid'. Segment score 2: 'minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well'. Segment score 3: 'entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and/or opaque liquid'. In this study, we define an excellent equivalent BBPS score as 8 or 9. Scores of 7 or above are generally felt to provide a good visualization of the colon.
1 secondary outcome
Patient tolerability to each 2L product
Time frame: 20 hours
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 20 Jun 2016.
- Background: PubMed 4017808Beck DE, Harford FJ, DiPalma JA. Comparison of cleansing methods in preparation for colonic surgery. Dis Colon Rectum. 1985 Jul;28(7):491-5. doi: 10.1007/BF02554091.
- Background: PubMed 16763922American Society of Colon and Rectal Surgeons (ASCRS); American Society for Gastrointestinal Endoscopy (ASGE); Society of American Gastrointestinal and Endoscopic Surgeons (SAGES); Wexner SD, Beck DE, Baron TH, Fanelli RD, Hyman N, Shen B, Wasco KE. A consensus document on bowel preparation before colonoscopy: prepared by a task force from the American Society of Colon and Rectal Surgeons (ASCRS), the American Society for Gastrointestinal Endoscopy (ASGE), and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Surg Endosc. 2006 Jul;20(7):1147-60. doi: 10.1007/s00464-006-0152-y. Epub 2006 Jun 8. No abstract available.
- Background: PubMed 9744604Hsu CW, Imperiale TF. Meta-analysis and cost comparison of polyethylene glycol lavage versus sodium phosphate for colonoscopy preparation. Gastrointest Endosc. 1998 Sep;48(3):276-82. doi: 10.1016/s0016-5107(98)70191-9.
- Background: PubMed 15257632Curran MP, Plosker GL. Oral sodium phosphate solution: a review of its use as a colorectal cleanser. Drugs. 2004;64(15):1697-714. doi: 10.2165/00003495-200464150-00009.
- Background: PubMed 2183591Vanner SJ, MacDonald PH, Paterson WG, Prentice RS, Da Costa LR, Beck IT. A randomized prospective trial comparing oral sodium phosphate with standard polyethylene glycol-based lavage solution (Golytely) in the preparation of patients for colonoscopy. Am J Gastroenterol. 1990 Apr;85(4):422-7.
- Background: PubMed 9102248Frommer D. Cleansing ability and tolerance of three bowel preparations for colonoscopy. Dis Colon Rectum. 1997 Jan;40(1):100-4. doi: 10.1007/BF02055690.
- Background: PubMed 7380204Davis GR, Santa Ana CA, Morawski SG, Fordtran JS. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980 May;78(5 Pt 1):991-5.
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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 Enns, MD, FRCP principal investigator
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 Phase 4 study testing Polyethylene Glycol (PEG) and 15 mg Bisacodyl and Polyethylene Glycol (PEG) + ascorbic acid in people with Colonoscopy, 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 1 inclusion and 4 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 20 Jun 2016. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bowel cleansing efficacy as rated by a Boston Bowel Preparation Scale score of greater than 8 (time frame: 20 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01865916, which also lists 7 linked publications.
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 20 Jun 2016.