Skip to main content
OpenTrials
Completed

NCT Number: NCT02618564

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colonoscopy Preparation Outcome

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hotel Dieu Hospital, Kingston, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sennosides

Drug

Each group will be assigned different doses of sennosides and varying times of administration

Other names: Senokot

Primary outcomes

  1. 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.

Secondary outcomes

  1. Colon cleansing, as measured by The Ottawa Scale and Aronchick Bowel Cleansing Scale

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2015
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.