Different Dosing Time of Bowklean for the Bowel Preparation

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of administration routine bowel cleansing medication (Bowklean) for the Bowel Preparation at Different Times Prior Colonoscopy in the morning or in the afternoon.

Detailed Description
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Sodium picosulfate/magnesium citrate (SPMC) is a small-volume bowel cleansing agent with similar efficacy and better tolerability than polyethylene glycol. However, there was limited data about the bowel cleansing efficacy of SPMC in comparing the same-day and split-dose preparation for afternoon colonoscopy. This randomized, single-center, endoscopist-blinded, non-inferior study compared same-day (101 subjects) and split-dose (96 subjects) preparation with SPMC for afternoon colonoscopy. One additional prospective observation group of 100 subjects receiving colonoscopy in the morning was included as an observation group to compare bowel preparation in morning and afternoon colonoscopy. Efficacy of bowel cleansing was evaluated by the Aronchick Scale, Ottawa Bowel Preparation Scale (OBPS), Boston Bowel Preparation Scale (BBPS), and the Bubble Scale (TBS).

Official Title
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Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study

Conditions
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Bowel Preparation

Intervention / Treatment
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* Drug: Bowklean


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 20 and 99 years, inclusive. Men or non-pregnant women who are scheduled for an elective colonoscopy. Subjects should be willing, able to complete the entire procedure and to comply with study instructions. Written informed consent obtained prior to study. Exclusion Criteria: Patients who are not suitable for colonoscopy Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.) Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD) Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudo- obstruction, hypomotility syndrome) Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus) Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), arrhythmia, cardiomyopathy or uncontrolled hypertension Renal insufficiency Any prior colorectal surgery in the past 3 months, excluding appendectomy, hemorrhoid surgery or prior endoscopic procedures History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass) Severe chronic constipation Hypersensitivity to any ingredient in the study medication

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The 1st group: split dose, day before, colonoscopy in the morning. The 2nd group: split dose, day before, colonoscopy in the afternoon. The 3rd group: same day, colonoscopy in the afternoon.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: split dose, day before, colonoscopy in the morning (Observation Group)<br>routine bowel preparation before colonoscopy in the morning | Drug: Bowklean<br>* assigned intervention<br>|
| Active Comparator: split dose, day before, colonoscopy in the afternoon (Random)<br>routine bowel preparation before colonoscopy in the afternoon | Drug: Bowklean<br>* assigned intervention<br>|
| Experimental: two dose in the same day, colonoscopy in the afternoon (Random)<br>experimental group | Drug: Bowklean<br>* assigned intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aronchick Scale Bowel Cleaning Scale | Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed | during colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale | The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3 | During Colonoscopy | 
| Colonscopy Bubble Scale | Colon Bubble Scale : Grade A : no bubble , Grade B: little bubble , Grade C: bubble of half of the lumen , Grade D: bubble of entire lumen. Grade A means the best and Grade D means the worst. | During Colonoscopy |