Colonoscopy Preparation OutcomeNCT02618564
The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
A study testing Sennosides in people with Colonoscopy Preparation Outcome, run by Queen's University at 2 sites in Canada.
Trial summary
The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colonoscopy Preparation Outcome
- What is being tested?
- Sennosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2016to Aug 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and non-pregnant female patients 18 to 75 years of age inclusive
- Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep
Who cannot join
- Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
- Ileus or bowel obstruction
- Previous colorectal surgery
- Ascites
- Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
- Pregnancy
- Recent (<6 months) myocardial infarction or unstable angina.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2
Hotel Dieu Hospital
Kingston, Ontario, K7L5G2
About this study
The objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
Read the detailed description
We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
- Conditions
- Colonoscopy Preparation Outcome
- Being tested
- Sennosides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SennosidesDrug
Also called Senokot
Each group will be assigned different doses of sennosides and varying times of administration
| Study group | Role | What they receive |
|---|---|---|
| 2 TABS QHS | Active comparator | Sennosides 2 tabs, taken two nights before the colonoscopy Receives: Drug: Sennosides |
| 3 TABS QHS | Active comparator | Sennosides 3 tabs, taken two nights before the colonoscopy Receives: Drug: Sennosides |
| 2 TABS AM | Active comparator | Sennosides 2 tabs, taken the morning before the colonoscopy Receives: Drug: Sennosides |
| 3 TABS AM | Active comparator | Sennosides 3 tabs, taken the morning before the colonoscopy Receives: Drug: Sennosides |
| 2 TABS AM & QHS | Active comparator | Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy. Receives: Drug: Sennosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel movements, as measured by patient diary
The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced.
Measured: 2 days
Secondary outcomes (2)
Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale
The secondary outcome is colon cleansing efficacy. The endoscopist will grade the cleansing quality of the colon using two standardized measures - the Ottawa Scale and the 5-point Aronchick Bowel Preparation Scale
Measured: 2 days
Tolerability, as measured by patient questionnaire
The secondary outcome is patient tolerability. Patients will be asked to complete a questionnaire examining symptoms such as nausea, bloating, vomiting, and abdominal pain.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonoscopy Preparation OutcomeStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 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 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618564
- Sponsor's protocol ID
- DMED#1845-15
- Status last verified
- May 2018
- First submitted
- 3 Oct 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
- ClinicalTrials.gov ID
- NCT02618564
- Acronym / sponsor ID
- DMED#1845-15
- Conditions
- Colonoscopy Preparation Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 1 Dec 2015 (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 objective of this study is to evaluate sennosides as an adjunct to sodium picosulfate magnesium citrate (Pico Salax) in preparation for colonoscopy. We will compare different doses and administration times. The primary outcome is number of bowel motions produced. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
Detailed description
We will compare different doses and administration times in patients booked for morning colonoscopy. The primary outcome is number of bowel motions produced in total by the sennosides. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2 TABS QHS | Active comparator | Drug: SennosidesSennosides 2 tabs, taken two nights before the colonoscopy |
| 3 TABS QHS | Active comparator | Drug: SennosidesSennosides 3 tabs, taken two nights before the colonoscopy |
| 2 TABS AM | Active comparator | Drug: SennosidesSennosides 2 tabs, taken the morning before the colonoscopy |
| 3 TABS AM | Active comparator | Drug: SennosidesSennosides 3 tabs, taken the morning before the colonoscopy |
| 2 TABS AM & QHS | Active comparator | Drug: SennosidesSennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and non-pregnant female patients 18 to 75 years of age inclusive
- Patients who require an outpatient colonoscopy with a split dose Pico-Salax prep
Key exclusion criteria (7 listed)
- Colonoscopy requiring the use of a large volume prep (eg Colyte, PEG)
- Ileus or bowel obstruction
- Previous colorectal surgery
- Ascites
- Recognized renal impairment (defined as GFR less than normal in 3 months prior to enrolment)
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 |
|---|---|---|
| SennosidesAlso: SenokotEach group will be assigned different doses of sennosides and varying times of administration | Drug | 2 TABS AM, 2 TABS AM & QHS, 2 TABS QHS, 3 TABS AM, 3 TABS QHS |
Primary outcome
Bowel movements, as measured by patient diary
Time frame: 2 days
The primary outcome of this pilot study is the number of bowel movements. Patients will record the timing and number of bowel motions produced.
2 secondary outcomes
Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale
Time frame: 2 days
Tolerability, as measured by patient questionnaire
Time frame: 2 days
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 9 May 2018.
- Individual participant dataSharing planned: No
Related trials for Colonoscopy Preparation Outcome
Not yet recruiting
Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing
Colonoscopy, Colonoscopy Diagnostic Techniques and Procedures
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sennosides in people with Colonoscopy Preparation Outcome, run by Queen's University at 2 sites 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 7 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Bowel movements, as measured by patient diary (time frame: 2 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 9 May 2018.