Status:
COMPLETED
Different Dosing Time of Bowklean for the Bowel Preparation
Lead Sponsor:
Changhua Christian Hospital
Conditions:
Bowel Preparation
Eligibility:
All Genders
20-99 years
Phase:
PHASE4
Brief Summary
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 mor...
Detailed Description
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 bo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
297 Patients enrolled
Trial Details
Trial ID
NCT04483037
Start Date
January 1 2019
End Date
December 31 2020
Last Update
July 23 2021
Active Locations (1)
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1
Hsu-Heng Yen
Changhua, Taiwan, 500