Bowel Preparation for ColonoscopyPhase 3BPNCT01415687
Split Dose Pico-Salax + Bisacodyl vs. PEG Split Dose
A Phase 3 study testing Polyethylene Glycol-Based Lavage and Pico-Salax (Magnesium Citrate) plus Bisacodyl in people with Bowel Preparation for Colonoscopy, run by University of Calgary at 2 sites in Canada.
Trial summary
The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness. Read more about this study
- Who is it for?
- Ages 18 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation for Colonoscopy
- What is being tested?
- Polyethylene Glycol-Based Lavage and Pico-Salax (Magnesium Citrate) plus Bisacodyl
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 2 sitesCanada
- Study dates
- May 2011to Dec 2011
- Phase
- Phase 3
- 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 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 to 74 years referred to the in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion
Who cannot join
- Any history of kidney problems
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Foranzi & MacPhail Colon Cancer Screening Centre, Alberta Health Services
Calgary, Alberta, T2N 4Z6
Foranzi & MacPhail Colon Cancer Screening Centre
Calgary, Alberta, T2N 4Z6
About this study
Official title: A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy
The objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness.
The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.
Read the detailed description
All patients referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients are asked to consider a general research consent. If they agree to that, then they will be approached for consideration of participating in this study and presented with an "Invitation to Participate in a Research Study" form (appendix); the study assistant will obtain final consent if they agree. Those not interested in participating will simply receive their physician's standard bowel preparation protocol. There will be no coercion of any sort. Enrollment of participants will be performed with block randomizations of 8 by using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) oral Pico-Salax (two sachets, with 1.5-2L of water following each sachet) with Dulcolax (Bisacodyl, 4 tablets); (2) split dose Polyethylene Glycol-Based Lavage (2L + 2L).
A study assistant will assign patients to their group and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the CCSC for the colonoscopy (included in the appendix). Patient concerns or questions regarding the preparation will be directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as to avoid un-blinding the Colonoscopist. The physician performing the procedure will then complete an Ottawa Bowel Preparation Scale and a validated Simplified Bowel Preparation scale to assess colon cleanliness.
- Conditions
- Bowel Preparation for Colonoscopy
- Being tested
- Polyethylene Glycol-Based Lavage, Pico-Salax (Magnesium Citrate) plus Bisacodyl
- Keywords
- preoperative care, colonoscopy, cathartics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene Glycol-Based LavageDrug
Also called Colyte
Split dose Polyethylene Glycol-Based Lavage (2L + 2L)
If arrival for colonoscopy is prior to 10AM: at 12 noon on the day before your colonoscopy drink 2L of PEG within two hours. At 8PM that day, drink the remaining 2L of PEG within two hours.
If arrival for colonoscopy is at or after 10AM: at 8PM on the day before your colonoscopy, drink 2L of PEG within two hours. Starting five hours before your arrival time at the Centre on the day of your colonoscopy, drink the remaining 2L of PEG within two hours.
Pico-Salax (Magnesium Citrate) plus BisacodylDrug
Also called Pico-Salax or Magnesium Citrate, Bisacodyl is also known as Dulcolax.
If arrival for colonoscopy is prior to 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 12 noon, drink the first packet of Pico-Salax in 8oz water, and the second packet of Pico-Salax in 8oz of water at 8PM. Day of colonoscopy, drink clear fluids.
If arrival for colonoscopy is at or after 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 8PM, drink the first packet of Pico-Salax in 8oz water. Day of colonoscopy, drink the second packet of Pico-Salax in 8oz water five hours before you are to arrive at the Centre.
| Study group | Role | What they receive |
|---|---|---|
| PEG Arm | Active comparator | Patients randomized to this arm of the trial will be following preparation instructions using Polyethylene Glycol-Based Lavage in a split dose format Receives: Drug: Polyethylene Glycol-Based Lavage |
| Pico-Salax + Bisacodyl Arm | Active comparator | Patients randomized to this arm will follow preparation instructions using Pico-Salax preparation plus Biscacodyl in a split dose format Receives: Drug: Pico-Salax (Magnesium Citrate) plus Bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Bowel Cleanliness
Ottawa bowel Prep scale will be done by the Dr. to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also, a complete 3-point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preparation would score 0-1; a good preparation, 2-4; while scores >4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of fluid. A simplified overall cleanliness score will be completed and compared to the Ottawa scale.
Measured: Scales provided to physician at time of colonoscopy, and filled out and collected after procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day as collection.
Secondary outcomes (1)
Patient Satisfaction with preparation
Patients will be given an anonymous tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the Centre for the colonoscopy. The tool asks questions of patient satisfaction with preparation, ease or difficulty of completing satisfaction, and side effects of the preparation method used.
Measured: Questionnaire given on day of pre-screen and collected on day of colonoscopy, approximately 3 weeks.Patients are not followed or contacted past the day of colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Preparation 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
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Rostom, University of Calgary
- Investigators
- Alaa Rostom, MD, Principal investigator, University of Calgary Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01415687
- Sponsor's protocol ID
- 23798
- Acronym
- BP
- Status last verified
- May 2012
- First submitted
- 5 Aug 2011
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rostom A, Dube C, Bishay K, Antonova L, Heitman SJ, Hilsden R. A randomized clinical prospective trial comparing split-dose picosulfate/ magnesium citrate and polyethylene glycol for colonoscopy preparation. PLoS One. 2019 Mar 28;14(3):e0211136. doi: 10.1371/journal.pone.0211136. eCollection 2019.
PubMed 30921345
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Prospective Trial Comparing Pico-Salax (Magnesium Citrate) Plus Bisacodyl Versus Split Dose Polyethylene Glycol-Based Lavage In Preparation Of Patients For Colonoscopy
- ClinicalTrials.gov ID
- NCT01415687
- Acronym / sponsor ID
- BP / 23798
- Conditions
- Bowel Preparation for Colonoscopy
- Keywords
- preoperative care, colonoscopy, cathartics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 12 Aug 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 objective of this study is to compare the efficacy, safety and tolerability of two bowel preparations for colonoscopy - split dose Polyethylene Glycol-Based Lavage and Pico-Salax plus Bisacodyl - with a specific emphasis on the right colon cleanliness.
The primary outcomes will be 1) quality of preparation in cleansing the colon, 2) quality of preparation in cleansing the right colon, 3) patient satisfaction. The secondary outcomes will be 1) duration of bowel preparation, 2) patient discomfort during bowel preparation.
Detailed description
All patients referred to the Forzani MacPhail Colon Cancer Screening Centre (CCSC) in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion. During pre-assessments at the clinic, patients are asked to consider a general research consent. If they agree to that, then they will be approached for consideration of participating in this study and presented with an "Invitation to Participate in a Research Study" form (appendix); the study assistant will obtain final consent if they agree. Those not interested in participating will simply receive their physician's standard bowel preparation protocol. There will be no coercion of any sort. Enrollment of participants will be performed with block randomizations of 8 by using a computer-generated table, with allocation concealment maintained through the use of consecutively numbered sealed envelopes. Colonoscopists and investigators will be blinded to allocation groups. Patients will be allocated to one of two groups: (1) oral Pico-Salax (two sachets, with 1.5-2L of water following each sachet) with Dulcolax (Bisacodyl, 4 tablets); (2) split dose Polyethylene Glycol-Based Lavage (2L + 2L).
A study assistant will assign patients to their group and instruct them on the proper use of their assigned bowel preparation method. Patients will be given a tolerability questionnaire, which has been modified from a previously used questionnaire, to be completed once their bowel preparation is finished and before coming to the CCSC for the colonoscopy (included in the appendix). Patient concerns or questions regarding the preparation will be directed toward the study assistant or clinic nurses as opposed to their endoscopist, so as to avoid un-blinding the Colonoscopist. The physician performing the procedure will then complete an Ottawa Bowel Preparation Scale and a validated Simplified Bowel Preparation scale to assess colon cleanliness.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG Arm | Active comparator | Drug: Polyethylene Glycol-Based LavagePatients randomized to this arm of the trial will be following preparation instructions using Polyethylene Glycol-Based Lavage in a split dose format |
| Pico-Salax + Bisacodyl Arm | Active comparator | Drug: Pico-Salax (Magnesium Citrate) plus BisacodylPatients randomized to this arm will follow preparation instructions using Pico-Salax preparation plus Biscacodyl in a split dose format |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 to 74 years referred to the in Calgary, Alberta, Canada for colonoscopy will be considered for inclusion
Key exclusion criteria (1 listed)
- Any history of kidney problems
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-Based LavageAlso: ColyteSplit dose Polyethylene Glycol-Based Lavage (2L + 2L) If arrival for colonoscopy is prior to 10AM: at 12 noon on the day before your colonoscopy drink 2L of PEG within two hours. At 8PM that day, drink the remaining 2L of PEG within two hours. If arrival for colonoscopy is at or after 10AM: at 8PM on the day before your colonoscopy, drink 2L of PEG within two hours. Starting five hours before your arrival time at the Centre on the day of your colonoscopy, drink the remaining 2L of PEG within two hours. | Drug | PEG Arm |
| Pico-Salax (Magnesium Citrate) plus BisacodylAlso: Pico-Salax or Magnesium Citrate, Bisacodyl is also known as Dulcolax.If arrival for colonoscopy is prior to 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 12 noon, drink the first packet of Pico-Salax in 8oz water, and the second packet of Pico-Salax in 8oz of water at 8PM. Day of colonoscopy, drink clear fluids. If arrival for colonoscopy is at or after 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 8PM, drink the first packet of Pico-Salax in 8oz water. Day of colonoscopy, drink the second packet of Pico-Salax in 8oz water five hours before you are to arrive at the Centre. | Drug | Pico-Salax + Bisacodyl Arm |
Primary outcome
Quality of Bowel Cleanliness
Time frame: Scales provided to physician at time of colonoscopy, and filled out and collected after procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day as collection.
Ottawa bowel Prep scale will be done by the Dr. to assess the quality of bowel cleanliness. The right, mid and rectosigmoid colon are each rated on a 5-point scale (0-4). Also, a complete 3-point rating for overall colonic fluid is assessed giving an overall score range of 0-14. An excellent preparation would score 0-1; a good preparation, 2-4; while scores >4 would indicate progressively worsening bowel preparations. A completely unprepared colon would score 11-14, depending on the amount of fluid. A simplified overall cleanliness score will be completed and compared to the Ottawa scale.
1 secondary outcome
Patient Satisfaction with preparation
Time frame: Questionnaire given on day of pre-screen and collected on day of colonoscopy, approximately 3 weeks.Patients are not followed or contacted past the day of colonoscopy.
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 31 May 2012.
- Derived from this study: PubMed 30921345Rostom A, Dube C, Bishay K, Antonova L, Heitman SJ, Hilsden R. A randomized clinical prospective trial comparing split-dose picosulfate/ magnesium citrate and polyethylene glycol for colonoscopy preparation. PLoS One. 2019 Mar 28;14(3):e0211136. doi: 10.1371/journal.pone.0211136. eCollection 2019.
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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.
Alaa Rostom, MD principal investigator
University of Calgary Faculty of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Polyethylene Glycol-Based Lavage and Pico-Salax (Magnesium Citrate) plus Bisacodyl in people with Bowel Preparation for Colonoscopy, run by University of Calgary at 2 sites 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 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 31 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Quality of Bowel Cleanliness (time frame: Scales provided to physician at time of colonoscopy, and filled out and collected after procedure is completed (1 hour time). Questionnaires are manually entered by an assistant into the study database on the same day as collection.). 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 NCT01415687, which also lists 1 linked publication.
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 31 May 2012.