ColonoscopyPhase 4NCT00380497
Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children
A Phase 4 study testing PEG-Lyte® and Pico-Salax® in people with Colonoscopy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Colonoscopy
- What is being tested?
- PEG-Lyte® and Pico-Salax®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2006to Sep 2007
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children between 4 and 18 years of age
- Undergoing full elective ambulatory colonoscopy
Who cannot join
- Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR<50 mls/min/1.73 m2)
- Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate >90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in children-a Single Blinded Randomized Controlled Trial
The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.
Read the detailed description
Good bowel cleanout before colonoscopy is commonly associated with significant discomfort that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by children who usually require the insertion of a nasogastric tube and a day admission. Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is administered in two divided doses, each in one cup of water; it is palatable and does not have to be given in hospital. However, no controlled study in children compared it with the current standard of care. Our preliminary experience and previous literature suggest that it is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized controlled trial. Positive results of this study will facilitate a better tolerated regimen for bowel clean out in children.
- Conditions
- Colonoscopy
- Being tested
- PEG-Lyte®, Pico-Salax®
- Keywords
- Pediatrics, Colonoscopy, Bowel cleanout, Poly-Ethylene Glycol, Pico-Salax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-Lyte®Drug
Pico-Salax®Drug
| Study group | Role | What they receive |
|---|---|---|
| Pico-Salax | Experimental | Not described Receives: Drug: Pico-Salax® |
| PEGlyte | Active comparator | Not described Receives: Drug: PEG-Lyte® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents
Secondary outcomes (2)
Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached
Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2007
- Study completionSep 2007
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.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Ling, The Hospital for Sick Children
- Investigators
- Simon Ling, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380497
- Sponsor's protocol ID
- 1000008846
- Status last verified
- Jul 2013
- First submitted
- 25 Sep 2006
- Last updated
- 29 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in children-a Single Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00380497
- Acronym / sponsor ID
- 1000008846
- Conditions
- Colonoscopy
- Keywords
- Pediatrics, Colonoscopy, Bowel cleanout, Poly-Ethylene Glycol, Pico-Salax
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 26 Sep 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.
The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.
Detailed description
Good bowel cleanout before colonoscopy is commonly associated with significant discomfort that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by children who usually require the insertion of a nasogastric tube and a day admission. Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is administered in two divided doses, each in one cup of water; it is palatable and does not have to be given in hospital. However, no controlled study in children compared it with the current standard of care. Our preliminary experience and previous literature suggest that it is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized controlled trial. Positive results of this study will facilitate a better tolerated regimen for bowel clean out in children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pico-Salax | Experimental | Drug: Pico-Salax® |
| PEGlyte | Active comparator | Drug: PEG-Lyte® |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children between 4 and 18 years of age
- Undergoing full elective ambulatory colonoscopy
Key exclusion criteria (2 listed)
- Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR<50 mls/min/1.73 m2)
- Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate >90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow
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 |
|---|---|---|
| PEG-Lyte® | Drug | PEGlyte |
| Pico-Salax® | Drug | Pico-Salax |
Primary outcome
Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents
2 secondary outcomes
Cleanout effectiveness (measured by: rating of a blinded gastroenterologist, the need for enema supplement, procedure length and whether the planned destination was reached
Side effects (measured by: dehydration assessment, questionnaires completed by the nurse and the patient, and blood tests)
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 29 Jul 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.
Simon Ling, MD principal investigator
The Hospital for Sick Children, Toronto Canada
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 PEG-Lyte® and Pico-Salax® in people with Colonoscopy, run by The Hospital for Sick Children 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 2 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 29 Jul 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?
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?
Patient's satisfaction from the regimen as assessed by a questionnaire completed by the child and parents. 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 29 Jul 2013.