Bowel CleansingPhase 3NCT01864915
Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
A Phase 3 study testing Prucalopride and Colon Capsule in people with Bowel Cleansing and Colon Capsule Completion Times, run by Queen's University at 1 site in Canada.
Trial summary
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bowel Cleansing, Colon Capsule Completion Times
- What is being tested?
- Prucalopride and Colon Capsule
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2013to Oct 2014
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 18-75 being referred for colonoscopy
Who cannot join
- symptoms of dysphagia or any problems with swallowing, bowel obstruction or ileus, known stricture or fistula, inflammatory bowel disease, previous small or large bowel surgery, severe gastroparesis or motility disorder, severe renal impairment ( defined as lab test result eGFR ie. estimated Glomerular Filtration Rate less than 55 within three months of study), congestive heart failure (NYHA III or IV), ischemic heart disease (acute event in the last 6mths), decompensated cirrhosis or severe hepatic dysfunction (ascites or known lab test INR>2), history of serious arrhythmia or any other severe and clinically unstable concomitant disease (eg. lung disease, neurological or psychiatric disorder, cancer, AIDS and other endocrine disorder) ,diabetics on treatment with insulin or hypoglycemic, pregnant or nursing women, galactose intolerance (since the tablets contain lactose monohydrate, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption must not take this medicinal product.) or known hypersensitivity to the drug or to any ingredient in the formulation (each 2mg tablet contains prucalopride 2 mg. Nonmedicinal ingredients: tablet core: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate; coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide, macrogol 3000, iron oxide red, iron oxide yellow, and FD\&C Blue No. 2 Aluminum Lake) Females of child bearing potential who are unwilling to use appropriate birth control methods during the study will not be able to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself.
Read the detailed description
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself
- Conditions
- Bowel Cleansing, Colon Capsule Completion Times
- Being tested
- Prucalopride, Colon Capsule
- Keywords
- colon capsule, bowel preparation, booster, prucalopride, picosalax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called RESTORAN
Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)
Colon CapsuleProcedure or surgery
Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.
| Study group | Role | What they receive |
|---|---|---|
| No Booster-low dose prucalopride booster | Experimental | low dose prucalopride booster arm Receives: Drug: Prucalopride; Procedure: Colon Capsule |
| Prucalopride Booster-high dose prucalopride booster | Experimental | additional 2mg prucalopride at time of capsule ingestion Receives: Drug: Prucalopride; Procedure: Colon Capsule |
| Picosalax Booster Arm | Experimental | One sachet of Picosalax 2hrs after capsule ingestion and 1/2 sachet at 4 hrs after swallowing colon capsule. Receives: Drug: Prucalopride; Procedure: Colon Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the quality of the bowel preparations
Colon capsule bowel prep assessed with previously used scale completed by designated gastroenterologists.
Colonoscopy bowel prep assessed by completion of Aronchick Scale by endoscopist performing procedure.
Measured: Day of colon capsule procedure and day of colonoscopy
Secondary outcomes (2)
Tolerance of Bowel Preparation with survey
Measured: Day of colonoscopy
Gastric, small bowel and colon transit time
Measured: Day of colon capsule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2013 (estimated)
- Study startJun 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel CleansingStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Hotel Dieu Hospital, Janssen Inc.
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01864915
- Sponsor's protocol ID
- DMED 1578-13 HOOKEY
- Other IDs
- 9427-D2773-21C
- Status last verified
- Feb 2017
- First submitted
- 25 May 2013
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: final analysis dataset shared with Janssen Inc (study sponsor)
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prucalopride + Prucalopride Booster vs. Prucalopride + Picosalax Booster for the Colon Capsule
- ClinicalTrials.gov ID
- NCT01864915
- Acronym / sponsor ID
- DMED 1578-13 HOOKEY
- Conditions
- Bowel Cleansing, Colon Capsule Completion Times
- Keywords
- colon capsule, bowel preparation, booster, prucalopride, picosalax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Hotel Dieu Hospital, Janssen Inc.
- Study start
- Jun 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 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.
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself.
Detailed description
Colon capsule endoscopy is a new technology that is a noninvasive method of examining the large bowel. The bowel preparation required for this test differs from colonoscopy in that it needs to clean the colon but also needs to provide propulsion. Most published studies have used medications as part of their regime that are not available in parts of North America (ex. sodium phosphate) and have shown poor test completion, bowel preparation and polyp detection rates.
Objective: In this study a bowel preparation for the colon capsule is proposed that uses medications approved for use in Canada that may provide a better preparation quality and better completion rates.
Methods: Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will all receive split-dose polyethylene glycol (PEG) for bowel preparation. They will be randomized to receive either 1) Prucalopride 2mg daily for four days, 2) Prucalopride 2mg daily for four days plus a Prucalopride booster, or 3) Prucalopride 2mg for four days plus 1 and 1/2 sachets of Picosalax boosters for the colon capsule study. The day after the colon capsule they will drink PEG ( 2 Liters) at 5am -or approx 4hrs prior to procedure time and return for a colonoscopy. The colon capsule results will be reviewed by two endoscopists experienced in video capsule endoscopy who will assess the bowel preparation using a previously defined scale and examine for polyps. We propose that administering Prucalopride daily for 4 days will increase intestinal motility and improve colon capsule completion rates and a booster dose of Picosalax will improve colon capsule completion rates compared to prucalopride by itself
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Booster-low dose prucalopride booster | Experimental | Drug: Prucalopride, Procedure: Colon Capsulelow dose prucalopride booster arm |
| Prucalopride Booster-high dose prucalopride booster | Experimental | Drug: Prucalopride, Procedure: Colon Capsuleadditional 2mg prucalopride at time of capsule ingestion |
| Picosalax Booster Arm | Experimental | Drug: Prucalopride, Procedure: Colon CapsuleOne sachet of Picosalax 2hrs after capsule ingestion and 1/2 sachet at 4 hrs after swallowing colon capsule. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients between the ages of 18-75 being referred for colonoscopy
Key exclusion criteria (1 listed)
- symptoms of dysphagia or any problems with swallowing, bowel obstruction or ileus, known stricture or fistula, inflammatory bowel disease, previous small or large bowel surgery, severe gastroparesis or motility disorder, severe renal impairment ( defined as lab test result eGFR ie. estimated Glomerular Filtration Rate less than 55 within three months of study), congestive heart failure (NYHA III or IV), ischemic heart disease (acute event in the last 6mths), decompensated cirrhosis or severe hepatic dysfunction (ascites or known lab test INR>2), history of serious arrhythmia or any other severe and clinically unstable concomitant disease (eg. lung disease, neurological or psychiatric disorder, cancer, AIDS and other endocrine disorder) ,diabetics on treatment with insulin or hypoglycemic, pregnant or nursing women, galactose intolerance (since the tablets contain lactose monohydrate, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose/galactose malabsorption must not take this medicinal product.) or known hypersensitivity to the drug or to any ingredient in the formulation (each 2mg tablet contains prucalopride 2 mg. Nonmedicinal ingredients: tablet core: lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, and magnesium stearate; coating: hypromellose, lactose monohydrate, triacetin, titanium dioxide, macrogol 3000, iron oxide red, iron oxide yellow, and FD\&C Blue No. 2 Aluminum Lake) Females of child bearing potential who are unwilling to use appropriate birth control methods during the study will not be able to participate in this clinical trial.
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 |
|---|---|---|
| PrucaloprideAlso: RESTORANPrucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study) | Drug | No Booster-low dose prucalopride booster, Picosalax Booster Arm, Prucalopride Booster-high dose prucalopride booster |
| Colon CapsuleColon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4. | Procedure or surgery | No Booster-low dose prucalopride booster, Picosalax Booster Arm, Prucalopride Booster-high dose prucalopride booster |
Primary outcome
To assess the quality of the bowel preparations
Time frame: Day of colon capsule procedure and day of colonoscopy
Colon capsule bowel prep assessed with previously used scale completed by designated gastroenterologists. Colonoscopy bowel prep assessed by completion of Aronchick Scale by endoscopist performing procedure.
2 secondary outcomes
Tolerance of Bowel Preparation with survey
Time frame: Day of colonoscopy
Gastric, small bowel and colon transit time
Time frame: Day of colon capsule
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 16 Feb 2017.
- Individual participant dataSharing planned: Yes. final analysis dataset shared with Janssen Inc (study sponsor)
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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.
Lawrence Hookey principal investigator
Queen's 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 Prucalopride and Colon Capsule in people with Bowel Cleansing and Colon Capsule Completion Times, 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 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 16 Feb 2017. 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?
To assess the quality of the bowel preparations (time frame: Day of colon capsule procedure and day of colonoscopy). 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 16 Feb 2017.