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

Colonoscopy Preparation Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02618564
• Other study ID #: DMED#1845-15
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: August 2017

Study information

• Verified date: May 2018
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Secondary outcomes include the quality of bowel cleansing and patient tolerability.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonoscopy Preparation Outcome

Intervention

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

Locations

Country	Name	City	State
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	Hotel Dieu Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	2 days
Secondary	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.	2 days