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

Queen's University

Status: Completed

Conditions: Colonoscopy Preparation Outcome

Treatments: Drug: Sennosides

Study type: Interventional

Funder types: Other

Identifiers

NCT02618564

DMED#1845-15

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 5 patient groups

2 TABS QHS

Active Comparator group

Description:

Sennosides 2 tabs, taken two nights before the colonoscopy

Treatment:

Drug: Sennosides

3 TABS QHS

Active Comparator group

Description:

Sennosides 3 tabs, taken two nights before the colonoscopy

Treatment:

Drug: Sennosides

2 TABS AM

Active Comparator group

Description:

Sennosides 2 tabs, taken the morning before the colonoscopy

Treatment:

Drug: Sennosides

3 TABS AM

Active Comparator group

Description:

Sennosides 3 tabs, taken the morning before the colonoscopy

Treatment:

Drug: Sennosides

2 TABS AM & QHS

Active Comparator group

Description:

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

Treatment:

Drug: Sennosides