Quality of Bowel Preparation for the Colon CapsulePhase 3NCT01655095
Improving Bowel Preparation for the Colon Capsule
A Phase 3 study testing PEG, Prucalopride and Picosalax in people with Quality of Bowel Preparation for the Colon Capsule and Colon Capsule Completion Rates, run by Queen's University at 1 site in Canada.
Trial summary
Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Quality of Bowel Preparation for the Colon Capsule, Colon Capsule Completion Rates, Colon Capsule Polyp Detection
- What is being tested?
- PEG, Prucalopride and Picosalax
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2012to Oct 2012
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female patients between the ages of 18 and 75
- Patients being referred for colonoscopy
Who cannot join
- Symptoms of dysphagia
- Bowel obstruction or ileus
- Known stricture or fistula
- Inflammatory bowel disease
- Previous small or large bowel surgery
- Severe gastroparesis or motility disorder
Show all 12Show fewer
- Renal impairment (GFR<55 within 3 months of study)
- Congestive heart failure (NYHA III or IV)
- Ischemic heart disease
- Cirrhosis or severe hepatic dysfunction (ascites or lab result INR>2)
- History of serious arrhythmia
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Bowel Preparation for the Colon Capsule: Picosalax and Prucalopride vs. PEG and Prucalopride
Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Most studies have been conducted in Europe using bowel preparation medications that are not approved for use in North America.
The purpose of this study is to compare a combination of polyethylene glycol (PEG) and prucalopride to Picosalax and prucalopride to determine which regime will give a better colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for use in Canada which improves intestinal motility and should help with colon capsule transit.
Read more
Patients who are being referred for colonoscopy will be enrolled in the study and randomized to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel preparation, patients randomized to the Picosalax group will take dulcolax three nights before the test and then again two nights before the test. The evening before the test patients will take either PEG 2L or one sachet of Picosalax. The following morning they will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they will return to the endoscopy unit where they will undergo a colonoscopy, which is the standard of care for examination of the colon.
The images from the colon capsule will be reviewed and the quality of bowel preparation will be graded using a previously validated scale. It is hypothesized that the Picosalax and prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be compared to polyps and abnormalities detected at the time of colonoscopy.
- Conditions
- Quality of Bowel Preparation for the Colon Capsule, Colon Capsule Completion Rates, Colon Capsule Polyp Detection
- Being tested
- PEG, Prucalopride, Picosalax, Bisacodyl, Colon capsule
- Keywords
- Colon capsule, Picosalax, PEG, Prucalopride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGDrug
PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.
PrucaloprideDrug
Prucalopride 2mg will be administered at 0800hrs on the day of the test, at the same time the colon capsule is administered. Two hours later the position of the colon capsule will be assess with a Realtime Viewer. If the capsule has not reached the cecum a second dose of Prucalopride 2mg will be administered at that time.
PicosalaxDrug
One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test
BisacodylDrug
Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.
Colon capsuleProcedure or surgery
The colon capsule will be ingested at 0800hrs the day of the test. Seven hours will be allowed for the capsule to clear the bowel. The images will be reviewed by two endoscopists with experience reading video capsule endoscopy.
ColonoscopyProcedure or surgery
At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| PEG and Prucalopride | Experimental | Not described Receives: Drug: PEG; Drug: Prucalopride; Procedure: Colon capsule; Procedure: Colonoscopy |
| Picosalax and Prucalopride | Experimental | Not described Receives: Drug: Prucalopride; Drug: Picosalax; Drug: Bisacodyl; Procedure: Colon capsule; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Quality of the Bowel Preparation using a previously defined scale.
Cleansing Scale:
- Poor: Mucosa obscured by opaque debris or turbid fluid
- Fair: Portion of the mucosa obscured by turbid fluid and/or debris preventing visualization of polyps >5mm in size
- Good: Fluid was clear and small pieces of debris not obscuring polyps >5mm
- Excellent: Fluid was clear and either free of debris or only small pieces
Bubble effect scale:
- Significant: Bubbles interfere with the examination, >10% surface area obscured by bubbles.
- Insignificant: No bubbles or bubbles that do not interfere with the examination, <10% of surface area obscured by bubbles.
Measured: Assessed at the time of review of the colon capsule images (from ingestion of capsule until the capsule is passed or the battery runs out--max 10 hrs) and at the time of colonoscopy on the same day (using a previously defined scale as described)
Number of individuals who have a complete colon capsule study (ie. pass the colon capsule prior to colonoscopy)
Measured: Assessed during the time of colon capsule image review
Secondary outcomes (3)
Assessment of patient tolerance of the bowel preparations.
Survey questionnaire to be completed by participants at the time of the colon capsule endoscopy assessing the tolerability of the preparation and side effects.
Measured: Assessed at the time of colon capsule ingestion (will cover time period from beginning of bowel preparation, as previously described, to ingestion of the colon capsule)
Gastric emptying and small and large bowel transit time
Determining the amount of time was required for the capsule to transit through the stomach, small bowel and large bowel for the two different preparations based on the images collected during the study.
Measured: Assessed at the time the colon capsule images are reviewed (will be monitored from time of capsule ingestion until capsule is expelled or battery runs out--max 10 hours)
Comparison of accurate identification of mucosal changes (ie. inflammation) and polyp detection with colonoscopy.
Abnormalities identified at the time the colon capsule images are reviewed will be compared to the abnormalities identified during the time of colonoscopy documented in the colonoscopy report.
Measured: Determined at the time of review of the colon capsule images (assessed from time of capsule ingestion until capsule is expelled or battery runs out--max. 10 hours) and assessed during the colonoscopy the same day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of Bowel Preparation for the Colon CapsuleStudies 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Hotel Dieu Hospital (Gastrointestinal Diseases Research Unit)
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, Principal investigator, Queens UniversityDarlene Brady, Study director, Queens University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655095
- Sponsor's protocol ID
- DMED-1478-12
- Status last verified
- Sep 2015
- First submitted
- 30 Jul 2012
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bowel Preparation for the Colon Capsule: Picosalax and Prucalopride vs. PEG and Prucalopride
- ClinicalTrials.gov ID
- NCT01655095
- Acronym / sponsor ID
- DMED-1478-12
- Conditions
- Quality of Bowel Preparation for the Colon Capsule, Colon Capsule Completion Rates, Colon Capsule Polyp Detection
- Keywords
- Colon capsule, Picosalax, PEG, Prucalopride
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Hotel Dieu Hospital (Gastrointestinal Diseases Research Unit)
- Study start
- Jul 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Aug 2012 (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.
Colon capsule endoscopy is a technology that has been developed as a noninvasive method of examining the large bowel. The biggest limitation to its use has been finding a bowel preparation that will both clean the colon adequately for good visualization of the mucosa and also help propel the capsule through the colon. Most studies have been conducted in Europe using bowel preparation medications that are not approved for use in North America.
The purpose of this study is to compare a combination of polyethylene glycol (PEG) and prucalopride to Picosalax and prucalopride to determine which regime will give a better colon cleanse for the colon capsule. Both PEG and Picosalax are bowel preparations that are used routinely for colonoscopy in Canada. Prucalopride is a new medication recently approved for use in Canada which improves intestinal motility and should help with colon capsule transit.
Patients who are being referred for colonoscopy will be enrolled in the study and randomized to one of the bowel preparation regimes. They will undergo a split-dose bowel preparation with either PEG or Picosalax, which is routine for colonoscopy. As part of the standard bowel preparation, patients randomized to the Picosalax group will take dulcolax three nights before the test and then again two nights before the test. The evening before the test patients will take either PEG 2L or one sachet of Picosalax. The following morning they will take another dose of either PEG (2 Liter container) or one sachet of Picosalax. They will then ingest the colon capsule and a dose of Prucalopride that morning. After 7 hours they will return to the endoscopy unit where they will undergo a colonoscopy, which is the standard of care for examination of the colon.
The images from the colon capsule will be reviewed and the quality of bowel preparation will be graded using a previously validated scale. It is hypothesized that the Picosalax and prucalopride regime will give a better cleanse for the colon than PEG and prucalopride as there will be less turbid fluid in the colon and allow for a better view of the mucosa. Polyp detection and abnormalities of the mucosa detected with the colon capsule will also be compared to polyps and abnormalities detected at the time of colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEG and Prucalopride | Experimental | Drug: PEG, Drug: Prucalopride, Procedure: Colon capsule, Procedure: Colonoscopy |
| Picosalax and Prucalopride | Experimental | Drug: Prucalopride, Drug: Picosalax, Drug: Bisacodyl, Procedure: Colon capsule, Procedure: Colonoscopy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients between the ages of 18 and 75
- Patients being referred for colonoscopy
Key exclusion criteria (12 listed)
- Symptoms of dysphagia
- Bowel obstruction or ileus
- Known stricture or fistula
- Inflammatory bowel disease
- Previous small or large bowel surgery
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 |
|---|---|---|
| PEGPEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test. | Drug | PEG and Prucalopride |
| PrucalopridePrucalopride 2mg will be administered at 0800hrs on the day of the test, at the same time the colon capsule is administered. Two hours later the position of the colon capsule will be assess with a Realtime Viewer. If the capsule has not reached the cecum a second dose of Prucalopride 2mg will be administered at that time. | Drug | PEG and Prucalopride, Picosalax and Prucalopride |
| PicosalaxOne sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test | Drug | Picosalax and Prucalopride |
| BisacodylBisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure. | Drug | Picosalax and Prucalopride |
| Colon capsuleThe colon capsule will be ingested at 0800hrs the day of the test. Seven hours will be allowed for the capsule to clear the bowel. The images will be reviewed by two endoscopists with experience reading video capsule endoscopy. | Procedure or surgery | PEG and Prucalopride, Picosalax and Prucalopride |
| ColonoscopyAt 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy. | Procedure or surgery | PEG and Prucalopride, Picosalax and Prucalopride |
Primary outcome
Assessment of the Quality of the Bowel Preparation using a previously defined scale.
Time frame: Assessed at the time of review of the colon capsule images (from ingestion of capsule until the capsule is passed or the battery runs out--max 10 hrs) and at the time of colonoscopy on the same day (using a previously defined scale as described)
Cleansing Scale: * Poor: Mucosa obscured by opaque debris or turbid fluid * Fair: Portion of the mucosa obscured by turbid fluid and/or debris preventing visualization of polyps >5mm in size * Good: Fluid was clear and small pieces of debris not obscuring polyps >5mm * Excellent: Fluid was clear and either free of debris or only small pieces Bubble effect scale: * Significant: Bubbles interfere with the examination, >10% surface area obscured by bubbles. * Insignificant: No bubbles or bubbles that do not interfere with the examination, <10% of surface area obscured by bubbles.
Number of individuals who have a complete colon capsule study (ie. pass the colon capsule prior to colonoscopy)
Time frame: Assessed during the time of colon capsule image review
3 secondary outcomes
Assessment of patient tolerance of the bowel preparations.
Time frame: Assessed at the time of colon capsule ingestion (will cover time period from beginning of bowel preparation, as previously described, to ingestion of the colon capsule)
Gastric emptying and small and large bowel transit time
Time frame: Assessed at the time the colon capsule images are reviewed (will be monitored from time of capsule ingestion until capsule is expelled or battery runs out--max 10 hours)
Comparison of accurate identification of mucosal changes (ie. inflammation) and polyp detection with colonoscopy.
Time frame: Determined at the time of review of the colon capsule images (assessed from time of capsule ingestion until capsule is expelled or battery runs out--max. 10 hours) and assessed during the colonoscopy the same day.
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 3 Dec 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.
Lawrence Hookey principal investigator
Queens University
Darlene Brady study director
Queens University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PEG, Prucalopride and Picosalax in people with Quality of Bowel Preparation for the Colon Capsule and Colon Capsule Completion Rates, run by Queen's University 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 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: finished, as of the sponsor's last update on 3 Dec 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 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?
Assessment of the Quality of the Bowel Preparation using a previously defined scale. (time frame: Assessed at the time of review of the colon capsule images (from ingestion of capsule until the capsule is passed or the battery runs out--max 10 hrs) and at the time of colonoscopy on the same day (using a previously defined scale as described)). The study lists 2 primary outcomes in all. 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 3 Dec 2015.