Different Dosing Time of Bowklean for the Bowel Preparation

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04483037
• Other study ID #: CCH IRB No.: 181216
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 morning or in the afternoon.

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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

Inclusion Criteria:

1. Subject is 20 and 99 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:

1. 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

2. 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)

3. Severe chronic constipation

4. Hypersensitivity to any ingredient in the study medication

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• Bowklean
assigned intervention

Locations

Country	Name	City	State
Taiwan	Hsu-Heng Yen	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aronchick Scale Bowel Cleaning Scale	Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed	during colonoscopy
Secondary	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
Secondary	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