The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
1 other identifier
interventional
100
1 country
2
Brief 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. Secondary outcomes include the quality of bowel cleansing and patient tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2016
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2015
CompletedFirst Posted
Study publicly available on registry
December 1, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedMay 9, 2018
May 1, 2018
1.6 years
October 3, 2015
May 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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.
2 days
Secondary Outcomes (2)
Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale
2 days
Tolerability, as measured by patient questionnaire
2 days
Study Arms (5)
2 TABS QHS
ACTIVE COMPARATORSennosides 2 tabs, taken two nights before the colonoscopy
3 TABS QHS
ACTIVE COMPARATORSennosides 3 tabs, taken two nights before the colonoscopy
2 TABS AM
ACTIVE COMPARATORSennosides 2 tabs, taken the morning before the colonoscopy
3 TABS AM
ACTIVE COMPARATORSennosides 3 tabs, taken the morning before the colonoscopy
2 TABS AM & QHS
ACTIVE COMPARATORSennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.
Interventions
Each group will be assigned different doses of sennosides and varying times of administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G2, Canada
Hotel Dieu Hospital
Kingston, Ontario, K7L5G2, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Hookey
Queen's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 3, 2015
First Posted
December 1, 2015
Study Start
January 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
May 9, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share