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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Colonoscopy Preparation Outcome

Intervention / Treatment
-----------------
* Drug: Sennosides


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2 TABS QHS<br>Sennosides 2 tabs, taken two nights before the colonoscopy | Drug: Sennosides<br>* Each group will be assigned different doses of sennosides and varying times of administration<br>* Other names: Senokot;|
| Active Comparator: 3 TABS QHS<br>Sennosides 3 tabs, taken two nights before the colonoscopy | Drug: Sennosides<br>* Each group will be assigned different doses of sennosides and varying times of administration<br>* Other names: Senokot;|
| Active Comparator: 2 TABS AM<br>Sennosides 2 tabs, taken the morning before the colonoscopy | Drug: Sennosides<br>* Each group will be assigned different doses of sennosides and varying times of administration<br>* Other names: Senokot;|
| Active Comparator: 3 TABS AM<br>Sennosides 3 tabs, taken the morning before the colonoscopy | Drug: Sennosides<br>* Each group will be assigned different doses of sennosides and varying times of administration<br>* Other names: Senokot;|
| Active Comparator: 2 TABS AM & QHS<br>Sennosides 2 tabs taken the morning before and 2 tabs taken the evening before the colonoscopy. | Drug: Sennosides<br>* Each group will be assigned different doses of sennosides and varying times of administration<br>* Other names: Senokot;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |