EndoscopyPhase 4COINNCT01627171
Colonoscopy Preparation Optimization for INpatients- COIN Study
A Phase 4 study testing Bisacodyl 10mg, Polyethelene Glycol and Picosulfate sodium in people with Endoscopy and Bowel Preparation Solutions, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy, Bowel Preparation Solutions
- What is being tested?
- Bisacodyl 10mg, Polyethelene Glycol and Picosulfate sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2012to Dec 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient colonoscopy
- Age greater than 18 years old
- Able to give consent
Who cannot join
- No consent obtained
- Pregnancy or lactating
- Renal impairment
- Severe CHF (NYHA class 3/4)
- Recent myocardial infarction (preceding 6 months)
- Ileus
Show all 13Show fewer
- Ascites
- Severe Colitis
- Toxic Megacolon
- Gastrointestinal Obstruction
- PEG tube
- Previous large bowel resection
- Allergy to study drug
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Joseph Hospital
Hamilton, Ontario, L8N4A6
Lisa Balogh-Melanson, BSc, 905-522-1155 ext. 33673, lbalogh@stjosham.on.ca
Khurram J Khan, MD,BSc
About this study
Official title: A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients
Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.
- Conditions
- Endoscopy, Bowel Preparation Solutions
- Being tested
- Bisacodyl 10mg, Polyethelene Glycol, Picosulfate sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisacodyl 10mgDrug
Given at the start of the bowel preparation the day before colonoscopy
Polyethelene GlycolDrug
Also called PEG-Lyte
280g reconstituted in 4 liters of water
Picosulfate sodiumDrug
Also called Pico-Salax
Two sachets, Each sachet has 10mg dose
| Study group | Role | What they receive |
|---|---|---|
| PEG Lyte | Active comparator | PEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy. Receives: Drug: Bisacodyl 10mg; Drug: Polyethelene Glycol |
| Pico Salax Split | Experimental | Two sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy. Receives: Drug: Bisacodyl 10mg; Drug: Picosulfate sodium |
| Pico Salax Night Before | Experimental | 2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy Receives: Drug: Bisacodyl 10mg; Drug: Picosulfate sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa Bowel Prep Score
Using a standardized, validated score for measuring quality of bowel preparation
Measured: 30 minutes after procedure
Secondary outcomes (4)
Procedures Cancelled or repeated due to inadequate bowel preparation
If bowel preparation is deemed inadequate to the point the procedure must be cancelled or rescheduled
Measured: During admission (average of 2 weeks)
Individual Components of Ottawa Bowel Prep Score
Each section of prep score evaluating the right, mid, and left colon, as well as the fluid score will be analyzed individually
Measured: 30 minutes after procedure
Adverse Effects
Any adverse effects that may be attributed to the intervention
Measured: Up to 48 hours after procedure
Tolerability of the preparation
A questionnaire to assess the overall tolerability of the preparation.
Measured: Within 1 day of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, Khurram Khan, St. Joseph's Healthcare Hamilton
- Investigators
- Khurram J Khan, MD, BSc, Principal investigator, St Josephs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01627171
- Sponsor's protocol ID
- RP 12-3657
- Acronym
- COIN
- Status last verified
- Jan 2013
- First submitted
- 19 Jun 2012
- Last updated
- 30 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Comparing 4L PEGlyte to Regular Dose Pico-Salax and Split Dose Pico-Salax for Colonoscopy Bowel Preparation in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01627171
- Acronym / sponsor ID
- COIN / RP 12-3657
- Conditions
- Endoscopy, Bowel Preparation Solutions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Sep 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 25 Jun 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.
Colonoscopic examinations are performed routinely in hospitalized patients for a variety of indications. However, numerous limitations exist in hospitalized patients preventing an endoscopist from performing high quality examinations; possibly necessitating repeated procedures leading to increased cost and re-exposure to their inherent risks. One such prominent challenge lays in the adequacy of bowel cleansing. Inpatient status has been shown to be a predictor of poor bowel preparation as these patients are older, less mobile and have more co morbidities than the outpatient population. Currently, no standardized (or optimized) bowel preparation type or regimen for administration exists for the hospital inpatient population undergoing colonoscopy. Studies in the outpatient population have demonstrated that timing and choice of cathartic medication effects the cleanliness of the bowel preparation but there is no such clinical evidence for in-patients who receive whatever cathartic agent is on hospital formulary. The purpose of the study is compare efficacy, patient satisfaction, and adverse effects associated with low volume cathartic (Pico-Salax) to the current standard volume 4 liter (PEG-Lyte) and the effect of alternate timing of dosages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEG Lyte | Active comparator | Drug: Bisacodyl 10mg, Drug: Polyethelene GlycolPEGlyte to be reconstituted with 4L of water and taken in the evening before the colonoscopy. |
| Pico Salax Split | Experimental | Drug: Bisacodyl 10mg, Drug: Picosulfate sodiumTwo sachets of Pico-Salax with 1 taken the night before colonoscopy and the second taken the morning of colonoscopy. |
| Pico Salax Night Before | Experimental | Drug: Bisacodyl 10mg, Drug: Picosulfate sodium2 sachets of Pico Salax mixed with water taken about 4 hours apart the night before colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Inpatient colonoscopy
- Age greater than 18 years old
- Able to give consent
Key exclusion criteria (13 listed)
- No consent obtained
- Pregnancy or lactating
- Renal impairment
- Severe CHF (NYHA class 3/4)
- Recent myocardial infarction (preceding 6 months)
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 |
|---|---|---|
| Bisacodyl 10mgGiven at the start of the bowel preparation the day before colonoscopy | Drug | PEG Lyte, Pico Salax Night Before, Pico Salax Split |
| Polyethelene GlycolAlso: PEG-Lyte280g reconstituted in 4 liters of water | Drug | PEG Lyte |
| Picosulfate sodiumAlso: Pico-SalaxTwo sachets, Each sachet has 10mg dose | Drug | Pico Salax Night Before, Pico Salax Split |
Primary outcome
Ottawa Bowel Prep Score
Time frame: 30 minutes after procedure
Using a standardized, validated score for measuring quality of bowel preparation
4 secondary outcomes
Procedures Cancelled or repeated due to inadequate bowel preparation
Time frame: During admission (average of 2 weeks)
Individual Components of Ottawa Bowel Prep Score
Time frame: 30 minutes after procedure
Adverse Effects
Time frame: Up to 48 hours after procedure
Tolerability of the preparation
Time frame: Within 1 day of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2013.
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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.
Khurram J Khan, MD, BSc principal investigator
St Josephs
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 Bisacodyl 10mg, Polyethelene Glycol and Picosulfate sodium in people with Endoscopy and Bowel Preparation Solutions, run by St. Joseph's Healthcare Hamilton 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 3 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 30 Jan 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Balogh Melanson, BSc (905-522-1155 ext. 33673, lbalogh@stjosham.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ottawa Bowel Prep Score (time frame: 30 minutes after procedure). 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 30 Jan 2013.