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The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing

Sponsor
Queen's University (Other)
Overall Status
Completed
CT.gov ID
NCT02618564
Collaborator
(none)
100
Enrollment
2
Locations
5
Arms
19
Actual Duration (Months)
50
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
The Use of Sennosides With Pico Salax in Bowel Preparation for Colonoscopy: a Study of Optimal Dose and Timing
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 2 TABS QHS

Sennosides 2 tabs, taken two nights before the colonoscopy

Drug: Sennosides
Each group will be assigned different doses of sennosides and varying times of administration
Other Names:
  • Senokot

    		•
    Active Comparator: 3 TABS QHS

    Sennosides 3 tabs, taken two nights before the colonoscopy

    Drug: Sennosides
    Each group will be assigned different doses of sennosides and varying times of administration
    Other Names:
  • Senokot

    		•
    Active Comparator: 2 TABS AM

    Sennosides 2 tabs, taken the morning before the colonoscopy

    Drug: Sennosides
    Each group will be assigned different doses of sennosides and varying times of administration
    Other Names:
  • Senokot

    		•
    Active Comparator: 3 TABS AM

    Sennosides 3 tabs, taken the morning before the colonoscopy

    Drug: Sennosides
    Each group will be assigned different doses of sennosides and varying times of administration
    Other Names:
  • Senokot

    		•
    Active Comparator: 2 TABS AM & QHS

    Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy.

    Drug: Sennosides
    Each group will be assigned different doses of sennosides and varying times of administration
    Other Names:
  • Senokot

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bowel movements, as measured by patient diary [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.

    Secondary Outcome Measures

    1. Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale [2 days]

      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

    2. Tolerability, as measured by patient questionnaire [2 days]

      The secondary outcome is patient tolerability. Patients will be asked to complete a questionnaire examining symptoms such as nausea, bloating, vomiting, and abdominal pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hotel Dieu Hospital Kingston Ontario Canada K7L 5G2
    2 Hotel Dieu Hospital Kingston Ontario Canada K7L5G2

    Sponsors and Collaborators

    • Queen's University

    Investigators

    • Principal Investigator: Lawrence Hookey, Queen's University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Lawrence Hookey, Principal Investigator, Queen's University
    ClinicalTrials.gov Identifier:
    NCT02618564
    Other Study ID Numbers:
    • DMED#1845-15
    First Posted:
    Dec 1, 2015
    Last Update Posted:
    May 9, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Sennosides

    Study Results

    No Results Posted as of May 9, 2018