Different Dosing Time of Bowklean for the Bowel Preparation

NCT ID: NCT04483037

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 297 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-12-31

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.

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).

Conditions

Bowel Preparation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

routine bowel preparation before colonoscopy in the morning

Group Type: ACTIVE_COMPARATOR

Bowklean

Intervention Type: DRUG

assigned intervention

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

routine bowel preparation before colonoscopy in the afternoon

Group Type: ACTIVE_COMPARATOR

Bowklean

Intervention Type: DRUG

assigned intervention

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

experimental group

Group Type: EXPERIMENTAL

Bowklean

Intervention Type: DRUG

assigned intervention

Interventions

Bowklean

assigned intervention

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changhua Christian Hospital

OTHER

Sponsor Role: lead

Responsible Party

HSUHENG YEN

Head of Endoscopy Room

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HsuHeng Yen, MD

Role: PRINCIPAL_INVESTIGATOR

Changhua Christian Hospital

Locations

Hsu-Heng Yen

Changhua, , Taiwan

Countries

Taiwan

Other Identifiers

CCH IRB No.: 181216

Identifier Type: -

Identifier Source: org_study_id