Different Dosing Time of Bowklean for the Bowel Preparation

• Sponsor: Changhua Christian Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04483037
• Collaborator: (none)
• Enrollment: 297
• Location: 1
• Arms: 3
• Actual Duration (Months): 24
• Patients Per Site Per Month: 12.4

Study Details

Study Description

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 morning or in the afternoon.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: Bowklean	Phase 4

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 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 297 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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)
• Primary Purpose: Other
• Official Title: Comparison of Same-Day and Split-Dose Preparation With Sodium Picosulfate/Magnesium Citrate (Bowklean) for Afternoon Colonoscopy: A Randomized Non-Inferiority Study
• Actual Study Start Date: Jan 1, 2019
• Actual Primary Completion Date: Dec 31, 2020
• Actual Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Aronchick Scale Bowel Cleaning Scale [during colonoscopy]

   Aroochick Scale ranges from score 1 : excellent, 2: good, 3: fair, 4: poor 5: failed

Secondary Outcome Measures

1. Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale [During Colonoscopy]

   The Boston Bowel Preparation Scale Score 0 : inadequate ; Score 1: fair ;Score 2: good; Score 3: excellent . min : 0 , max: 3

2. Colonscopy Bubble Scale [During Colonoscopy]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

1. 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)

1. Severe chronic constipation

2. Hypersensitivity to any ingredient in the study medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hsu-Heng Yen	Changhua		Taiwan	500

Sponsors and Collaborators

• Changhua Christian Hospital

Investigators

• Principal Investigator: HsuHeng Yen, MD, Changhua Christian Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HSUHENG YEN, Head of Endoscopy Room, Changhua Christian Hospital
• ClinicalTrials.gov Identifier: NCT04483037
• Other Study ID Numbers: CCH IRB No.: 181216
• First Posted: Jul 23, 2020
• Last Update Posted: Jul 23, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 23, 2021