Bowel PreparationPhase 4NCT02070341
Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose PEG
A Phase 4 study testing Polyethylene Glycol and Picosalax in people with Bowel Preparation, run by Queen's University at 1 site in Canada.
Trial summary
Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation
- What is being tested?
- Polyethylene Glycol and Picosalax
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Jul 2014
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy
Who cannot join
- ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (<6 months) myocardial infarction or unstable angina
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Examining Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose Polyethylene Glycol
Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.
- Conditions
- Bowel Preparation
- Being tested
- Polyethylene Glycol, Picosalax
- Keywords
- patient tolerability, quality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyethylene GlycolDrug
PicosalaxDrug
| Study group | Role | What they receive |
|---|---|---|
| Split dose PEG | Experimental | Patients randomized to the Polyethylene Glycol (PEG) group will be instructed to ingest 2L of bowel preparation the night before their colonoscopy (starting at 7PM), as well as 1.5-2L of carbohydrate-electrolyte rehydration solution. The following day they will be instructed to ingest the remaining 2L of bowel preparation and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. Receives: Drug: Polyethylene Glycol |
| Split dose Picosalax | Experimental | Patients randomized to the Picosalax (P/MC) group will be instructed to mix one sachet in 150mL of water and ingest the entire mixture at 7PM the night before their colonoscopy. In addition, they will be instructed to ingest 1.5-2L of carbohydrate-electrolyte rehydration solution after they consume the P/MC sachet. The following day they will mix the second sachet in 150mL of water and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. They will also be instructed to drink additional carbohydrate-electrolyte rehydration solution after they ingest the P/MC sachet. Receives: Drug: Picosalax |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient tolerability
Patients will be asked to complete a questionnaire to assess ease of completion and symptoms. Questionnaire items are weighted on a 5-point Likert scale. Interference with sleep will be assessed through a questionnaire that is based on a modified validated sleep questionnaire (St. Mary's Hospital Sleep Questionnaire). Participants will be asked to complete this questionnaire at the initial appointment and again on the day of their procedure
Measured: Two days
Secondary outcomes (1)
Quality of bowel preparation
The colonoscopist will be blinded to the type of preparation the subject underwent. The colonoscopist will complete a validated questionnaire to assess the quality of the preparation (The Ottawa Scale) and the 4-point Aronchick bowel cleansing scale. The patient's baseline bowel habit will be recorded, as well as the withdrawal time, volume of liquid suctioned and volume of washing fluid used during the colonoscopy.
Measured: During colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Significant changes to protocol and study design, study stopped to further enrollment and new study designed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lawrence Hookey, Queen's University
- Investigators
- Lawrence Hookey, Principal investigator, Queen's UniversityStephen Vanner, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070341
- Sponsor's protocol ID
- Hookey Picosalax PEG
- Status last verified
- Sep 2015
- First submitted
- 20 Feb 2014
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Examining Patient Tolerability and Efficacy of Bowel Preparation With Split Dose Picosalax vs. Split Dose Polyethylene Glycol
- ClinicalTrials.gov ID
- NCT02070341
- Acronym / sponsor ID
- Hookey Picosalax PEG
- Conditions
- Bowel Preparation
- Keywords
- patient tolerability, quality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Significant changes to protocol and study design, study stopped to further enrollment and new study designed.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Feb 2014 (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.
Introduction: Colonoscopy is an important tool for colon cancer screening. Proper colon cleansing is essential to ensure adequate mucosal examination. Timing of bowel preparation administration is now recognized as an important component for achieving superior cleansing. Multiple randomized controlled trials and meta-analyses have found split-dosing to be superior than day-before dosing. Objective: This study aims to compare two types of bowel preparations in split-doses to assess for differences in patient tolerability, as well as efficacy of colon cleansing. Methods: This is a prospective, single-blinded, randomized-controlled trial. Patients who are being referred for a colonoscopy will be recruited to participate in the study. They will be randomly assigned to receive either a split-dose polyethylene glycol (PEG) or picosalax (P/MC) bowel preparation. Patient tolerability will be examined through questionnaires. The endoscopist performing the colonoscopy will use two standardized bowel preparation scoring systems to evaluate the quality of the cleansing. The investigators propose that P/MC will be superior to PEG in patient tolerability and non-inferior in bowel cleansing effects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split dose PEG | Experimental | Drug: Polyethylene GlycolPatients randomized to the Polyethylene Glycol (PEG) group will be instructed to ingest 2L of bowel preparation the night before their colonoscopy (starting at 7PM), as well as 1.5-2L of carbohydrate-electrolyte rehydration solution. The following day they will be instructed to ingest the remaining 2L of bowel preparation and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. |
| Split dose Picosalax | Experimental | Drug: PicosalaxPatients randomized to the Picosalax (P/MC) group will be instructed to mix one sachet in 150mL of water and ingest the entire mixture at 7PM the night before their colonoscopy. In addition, they will be instructed to ingest 1.5-2L of carbohydrate-electrolyte rehydration solution after they consume the P/MC sachet. The following day they will mix the second sachet in 150mL of water and must finish ingesting the entire preparation at least 4 hours prior to the scheduled colonoscopy. They will also be instructed to drink additional carbohydrate-electrolyte rehydration solution after they ingest the P/MC sachet. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All male and non-pregnant female patients between ages 18 and 75 years old who require outpatient colonoscopy
Key exclusion criteria (1 listed)
- ileus or bowel obstruction, previous colorectal surgery, ascites, recognized renal impairment, defined as GFR less than normal in 3 months prior to enrollment, active inflammatory bowel disease, insulin dependent diabetes, pregnancy, or recent (<6 months) myocardial infarction or unstable angina
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 | Drug | Split dose PEG |
| Picosalax | Drug | Split dose Picosalax |
Primary outcome
Patient tolerability
Time frame: Two days
Patients will be asked to complete a questionnaire to assess ease of completion and symptoms. Questionnaire items are weighted on a 5-point Likert scale. Interference with sleep will be assessed through a questionnaire that is based on a modified validated sleep questionnaire (St. Mary's Hospital Sleep Questionnaire). Participants will be asked to complete this questionnaire at the initial appointment and again on the day of their procedure
1 secondary outcome
Quality of bowel preparation
Time frame: During colonoscopy
Results and safety
The study was stopped early (reason given: Significant changes to protocol and study design, study stopped to further enrollment and new study designed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
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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
Stephen Vanner 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 4 study testing Polyethylene Glycol and Picosalax in people with Bowel Preparation, 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: stopped early, as of the sponsor's last update on 28 Sep 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 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 was stopped early (reason given: Significant changes to protocol and study design, study stopped to further enrollment and new study designed.). Results are not available in the source record.
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?
Patient tolerability (time frame: Two days). 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 28 Sep 2015.