Clinical Trials List
Protocol NumberUIC-BKL-2013
2013-08-01 - 2014-08-31
Phase III
Terminated2
A Prospective, Randomized Controlled Clinical Study of the Efficacy and Safety of Bowklean and Klean-Prep with Dulcolax for the Bowel Preparation Prior Colonoscopy
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Trial Applicant
STATPLUS, INC.
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Sponsor
-
Trial scale
Taiwan Multiple Center
-
Update
2025/08/20
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Completed
Co-Principal Investigator
- 張伸吉 Division of Colorectal Surgery
- 江驊哲 Division of Colorectal Surgery
- Tao-Wei Ke Division of Colorectal Surgery
- 謝右文 藥劑部主任
The Actual Total Number of Participants Enrolled
0 Completed
Condition/Disease
subjects undergoing colonoscopy
Objectives
The objective of this study is to demonstrate that investigational medication (Bowklean) is not less
effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality
of bowel preparation in subjects undergoing colonoscopy. It is designed to measure the number of
subjects whose colons are cleansed successfully.
Test Drug
Bowklean
Active Ingredient
Dosage Form
Dosage
10
12
3.5
12
3.5
Endpoints
Analysis of Primary Variable
The primary efficacy variable is the percentage of subjects who achieve excellent or good in overall
Analysis of Secondary Variables
Proportion of successes (excellent, good, or fair) assessed with the Ottawa scale
Mean bowel preparation score assessed with Ottawa Scale
Percentage of subject’s responses to the acceptability and tolerability
The primary efficacy variable is the percentage of subjects who achieve excellent or good in overall
Analysis of Secondary Variables
Proportion of successes (excellent, good, or fair) assessed with the Ottawa scale
Mean bowel preparation score assessed with Ottawa Scale
Percentage of subject’s responses to the acceptability and tolerability
Inclution Criteria
Inclusion Criteria
1. Subject is 20 and 80 years, inclusive.
2. Men or non-pregnant women who are scheduled for an elective colonoscopy.
3. Subjects should be willing, able to complete the entire procedure and to comply with study
instructions.
4. Written informed consent obtained prior to study.
1. Subject is 20 and 80 years, inclusive.
2. Men or non-pregnant women who are scheduled for an elective colonoscopy.
3. Subjects should be willing, able to complete the entire procedure and to comply with study
instructions.
4. Written informed consent obtained prior to study.
Exclusion Criteria
Exclusion Criteria
1. Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
2. Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
3. Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
4. Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus)
5. Any prior colorectal surgery in the past 3 months, excluding appendectomy, hemorrhoid surgery
or prior endoscopic procedures
6. History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
7. Severe chronic constipation
8. Ascites
9. Renal insufficiency (serum creatinine > 1.5 times the upper limit of normal (ULN))
10. Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before
randomization, Congestive Heart Failure (CHF), or uncontrolled hypertension
11. Participation in an investigational study within 60 days prior to receiving study medication
12. Any clinically significant laboratory value at screening, including pre-existing electrolyte
abnormality, based on clinical history that the Investigator feels may affect the study evaluation
13. Hypersensitivity to any ingredient in the study medication
1. Acute surgical abdominal conditions (e.g. acute obstruction or perforation, etc.)
2. Active (acute/exacerbation of/severe/uncontrolled) Inflammatory Bowel Disease (IBD)
3. Colon disease (history of colonic cancer, toxic megacolon, toxic colitis, idiopathic pseudoobstruction, hypomotility syndrome)
4. Gastrointestinal disorder (active ulcer, outlet obstruction, gastric retention, gastroparesis, ileus)
5. Any prior colorectal surgery in the past 3 months, excluding appendectomy, hemorrhoid surgery
or prior endoscopic procedures
6. History of upper gastrointestinal surgery (gastric resection, gastric banding, gastric by-pass)
7. Severe chronic constipation
8. Ascites
9. Renal insufficiency (serum creatinine > 1.5 times the upper limit of normal (ULN))
10. Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before
randomization, Congestive Heart Failure (CHF), or uncontrolled hypertension
11. Participation in an investigational study within 60 days prior to receiving study medication
12. Any clinically significant laboratory value at screening, including pre-existing electrolyte
abnormality, based on clinical history that the Investigator feels may affect the study evaluation
13. Hypersensitivity to any ingredient in the study medication
The Estimated Number of Participants
-
Taiwan
600 participants
-
Global
600 participants
