Different Dosing Time of Bowklean for the Bowel Preparation

NCT04483037 | Completed Phase 4

• 1 other identifier: CCH IRB No.: 181216
• Study Type: interventional
• Target: 297
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation

Outcome Measures

Primary Outcomes (1)

• Aronchick Scale Bowel Cleaning Scale

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

  during colonoscopy

Secondary Outcomes (2)

• Boston Bowel Preparation Scale (BBPS) Bowel Cleaning Scale

  During Colonoscopy

• Colonscopy Bubble Scale

  During Colonoscopy

Study Arms (3)

split dose, day before, colonoscopy in the morning (Observation Group)

ACTIVE COMPARATOR

routine bowel preparation before colonoscopy in the morning

Drug: Bowklean

split dose, day before, colonoscopy in the afternoon (Random)

ACTIVE COMPARATOR

routine bowel preparation before colonoscopy in the afternoon

Drug: Bowklean

two dose in the same day, colonoscopy in the afternoon (Random)

EXPERIMENTAL

experimental group

Drug: Bowklean

Interventions

Bowklean DRUG

assigned intervention

split dose, day before, colonoscopy in the afternoon (Random); split dose, day before, colonoscopy in the morning (Observation Group); two dose in the same day, colonoscopy in the afternoon (Random)

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhua Christian Hospital: lead

Study Sites (1)

Hsu-Heng Yen

Changhua, 500, Taiwan

Location

Study Officials

• HsuHeng Yen, MD

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Endoscopy Room

Model Details: 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.

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 23, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)