ColonoscopyPhase 4NCT00410215
A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
A Phase 4 study testing picosalax plus bisacodyl, picosalax and sodium phosphate in people with Colonoscopy, run by Queen's University at 1 site in Canada.
Trial summary
Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- picosalax plus bisacodyl, picosalax and sodium phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2006to Jan 2008
- 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
- Consecutive male and non-pregnant female patients
- ≥ 18 years old
- who require outpatient colonoscopy will be approached to consider participation in the study.
Who cannot join
- ileus or bowel obstruction;
- previous colorectal surgery;
- renal impairment;
- pregnancy;
- recent (<6 months) myocardial infarction or unstable angina.
Trial locations and contacts
1 site in 1 country.
About this study
Colon cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate the preparation. Pico-salax has recently been introduced in Canada as an alternative agent and is being used more and more widely despite an almost complete lack of clinical data supporting efficacy and safety. This study will establish the relative efficacy and patient tolerability of this agent and its safety profile. This is a very important, practical issue which continues to challenge gastroenterologists, surgeons, internists, family doctors and thousands of their patients in Canada on a daily basis.
Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.
Read the detailed description
This is a randomized, investigator blinded clinical trial assessing the cleansing efficacy (using the Ottawa Bowel Preparation scale) and tolerance of three bowel cleansing regimens, two of which involve pico-salax.
- Conditions
- Colonoscopy
- Being tested
- picosalax plus bisacodyl, picosalax, sodium phosphate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
picosalax plus bisacodylDrug
10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax
picosalaxDrug
two sachets of picosalax taken orally the day prior to colonoscopy
sodium phosphateDrug
two 45 ml bottles of sodium phosphate the day prior to colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | sodium phosphate Receives: Drug: sodium phosphate |
| 2 | Active comparator | picosalax Receives: Drug: picosalax |
| 3 | Active comparator | picosalax plus bisacodyl Receives: Drug: picosalax plus bisacodyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ottawa Bowel Preparation scale
Measured: At Colonoscopy.
Secondary outcomes (2)
Tolerance-Likert scale questionnaire
Measured: After Preparation.
Safety Hemodynamics, Blood Chemistry
Measured: After Preparation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startFeb 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 315 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 C Hookey, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410215
- Sponsor's protocol ID
- hookey picosalax
- Status last verified
- Sep 2015
- First submitted
- 8 Dec 2006
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Picosalax and Oral Sodium Phosphate for Colon Cleansing Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT00410215
- Acronym / sponsor ID
- hookey picosalax
- Conditions
- Colonoscopy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Dec 2006 (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 cleansing prior to colonoscopy is critically important to ensure effective colonoscopy for colon cancer screening, which is now widespread in North America. Currently available colon cleansing agents are limited either by potential safety concerns or significant limitations in the ability of patients to tolerate the preparation. Pico-salax has recently been introduced in Canada as an alternative agent and is being used more and more widely despite an almost complete lack of clinical data supporting efficacy and safety. This study will establish the relative efficacy and patient tolerability of this agent and its safety profile. This is a very important, practical issue which continues to challenge gastroenterologists, surgeons, internists, family doctors and thousands of their patients in Canada on a daily basis.
Anecdotal evidence suggests that the efficacy of pico-salax when used as a sole agent may not be as efficacious as oral sodium phosphate. Hence, our hypothesis is that the combination of pico-salax and bisacodyl will provide the most efficacious bowel preparation in comparison with oral sodium phosphate and pico-salax alone, while being equally if not better tolerated.
Detailed description
This is a randomized, investigator blinded clinical trial assessing the cleansing efficacy (using the Ottawa Bowel Preparation scale) and tolerance of three bowel cleansing regimens, two of which involve pico-salax.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: sodium phosphatesodium phosphate |
| 2 | Active comparator | Drug: picosalaxpicosalax |
| 3 | Active comparator | Drug: picosalax plus bisacodylpicosalax plus bisacodyl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consecutive male and non-pregnant female patients
- ≥ 18 years old
- who require outpatient colonoscopy will be approached to consider participation in the study.
Key exclusion criteria (5 listed)
- ileus or bowel obstruction;
- previous colorectal surgery;
- renal impairment;
- pregnancy;
- 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 |
|---|---|---|
| picosalax plus bisacodyl10 mg bisacodyl three and two nights prior to colonoscopy, followed by two sachets picosalax | Drug | 3 |
| picosalaxtwo sachets of picosalax taken orally the day prior to colonoscopy | Drug | 2 |
| sodium phosphatetwo 45 ml bottles of sodium phosphate the day prior to colonoscopy | Drug | 1 |
Primary outcome
Ottawa Bowel Preparation scale
Time frame: At Colonoscopy.
2 secondary outcomes
Tolerance-Likert scale questionnaire
Time frame: After Preparation.
Safety Hemodynamics, Blood Chemistry
Time frame: After Preparation.
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 22 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 C Hookey, MD 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 picosalax plus bisacodyl, picosalax and sodium phosphate in people with Colonoscopy, 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 3 inclusion and 5 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 22 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 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?
Ottawa Bowel Preparation scale (time frame: At 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 22 Sep 2015.