ColonoscopyNCT01452737
Comparing 4L Golytely to 2L Golytely With 15mg Bisacodyl Regimens for Inpatient Colonic Preparation
A study testing Standard Bowel Prep and 2L Golytely/bisacodyl in people with Colonoscopy, run by University of British Columbia at 1 site in Canada.
Trial summary
The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colonoscopy
- What is being tested?
- Standard Bowel Prep and 2L Golytely/bisacodyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to May 2012
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients undergoing colonoscopy
- Age 19 or over
Who cannot join
- Unable to provide informed consent
- Patients with constipation
- Patients with suspected bowel obstruction or severe inflammatory bowel disease
- Same-day colonoscopy
- Intensive/critical care patient
- History of colorectal resection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial
The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.
- Conditions
- Colonoscopy
- Being tested
- Standard Bowel Prep, 2L Golytely/bisacodyl
- Keywords
- colonoscopy, bowel preparation, Golytely
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Bowel PrepDrug
Subjects will be asked to take 4L of Golytely the day prior to procedure.
2L Golytely/bisacodylDrug
Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.
| Study group | Role | What they receive |
|---|---|---|
| 2L Golytely/15mg bisacodyl | Experimental | Subjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy. Receives: Drug: 2L Golytely/bisacodyl |
| Standard bowel prep | Active comparator | Subject will receive standard bowel prep (4L Golytely) prior to colonoscopy. Receives: Drug: Standard Bowel Prep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups
These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
Measured: 30min
Secondary outcomes (2)
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups
Measured: 20hours
Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.
Measured: 20hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2012
- Study completionMay 2012
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 University of British ColumbiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A. Enns, Dr., Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452737
- Sponsor's protocol ID
- H11-02318
- Status last verified
- Sep 2013
- First submitted
- 12 Oct 2011
- Last updated
- 19 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2L Golytely and Oral Bisacodyl 15 mg Versus 4L Golytely Regimen for Inpatient Colonoscopy Bowel Preparation: A Randomized, Non-Inferiority Open Trial
- ClinicalTrials.gov ID
- NCT01452737
- Acronym / sponsor ID
- H11-02318
- Conditions
- Colonoscopy
- Keywords
- colonoscopy, bowel preparation, Golytely
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Oct 2011 (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 investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Golytely (PEG + electrolytes) plus 15mg of bisacodyl vs the standard preparation of 4L Golytely. The investigators hypothesize that 2L Golytely with 15mg bisacodyl will show similar bowel cleansing efficacy while offering better tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2L Golytely/15mg bisacodyl | Experimental | Drug: 2L Golytely/bisacodylSubjects will be asked to take 2L Golytely + 15mg bisacodyl for bowel prep the day before colonoscopy. |
| Standard bowel prep | Active comparator | Drug: Standard Bowel PrepSubject will receive standard bowel prep (4L Golytely) prior to colonoscopy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients undergoing colonoscopy
- Age 19 or over
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Patients with constipation
- Patients with suspected bowel obstruction or severe inflammatory bowel disease
- Same-day colonoscopy
- Intensive/critical care patient
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 |
|---|---|---|
| Standard Bowel PrepSubjects will be asked to take 4L of Golytely the day prior to procedure. | Drug | Standard bowel prep |
| 2L Golytely/bisacodylSubjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure. | Drug | 2L Golytely/15mg bisacodyl |
Primary outcome
Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups
Time frame: 30min
These are established rating scales to evaluate the quality of bowel prep. The ratings will be compared between the two groups.
2 secondary outcomes
Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups
Time frame: 20hours
Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.
Time frame: 20hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Robert A. Enns, Dr. principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Bowel Prep and 2L Golytely/bisacodyl in people with Colonoscopy, run by University of British Columbia 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 6 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: withdrawn, as of the sponsor's last update on 19 Sep 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Difference in Boston Bowel Preparation Scale & Ottawa Bowel Preparation Scale between the two groups (time frame: 30min). 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 19 Sep 2013.