A Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy

A Prospective, Randomized Controlled Clinical Study of the Efficacy and Safety of Bowklean and Klean-Prep With Dulcolax for the Bowel Preparation Prior Colonoscopy

The primary objective of this study is to demonstrate that investigation medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. An additional objective of this study is to collect subject's response to the acceptability and tolerability about bowel preparation and safety information.

After bowel preparation, independent evaluator who is blinded to subject's treatment will evaluate the overall colon cleansing based on Aronchick and Ottawa scale. A total of 600 eligible subjects scheduled to a colonoscopy will be randomly assigned with equal allocation to 1 of 2 treatment groups: "Bowklean" or "Klean-Prep" with Dulcolax. Each subject's participation is expected to be maximally 4 weeks in study duration (up to 3-week screening period followed by one week post colonoscopy).

Study Overview

• Status: Completed
• Conditions: Bowel Preparation Before Colonoscopy
• Intervention / Treatment: Drug: Picosulfate sodium, magnesium oxide, citric acid

Detailed Description

The objective of this study was to demonstrate that investigational medication (Bowklean) is not less effective than the active comparator (Klean-Prep with Dulcolax), with regards to the overall quality of bowel preparation in subjects undergoing colonoscopy. It was designed to measure the number of subjects whose colons are cleansed successfully.

The primary efficacy endpoint is the percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.

The secondary efficacy variables include:

1. Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale6.
2. Mean bowel preparation score assessed with Ottawa Scale by adding points for the cleansing of three parts of colon and points for amount of fluid in the bowel.
3. Percentage of subject's responses to the acceptability and tolerability

Safety was assessed at each clinic visit by evaluation of the following variables:

1. Percentage of subjects occurred solicited event (nausea, vomiting, chest pain and dizziness) during the preparation.
2. Percentage of subjects with treatment-emergent adverse events during the study period.

• Study Type: Interventional
• Enrollment (Actual): 631
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 40447
    • China Medical University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is 20 and 80 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 Criteria:

• 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)
• 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
• Ascites
• Renal insufficiency ((serum creatinine > 1.5 times the upper limit of normal (ULN))creatinine clearance < 30 mL/min)
• Uncontrolled angina and/or Myocardial Infarction (MI) within last 3 months before randomization, Congestive Heart Failure (CHF), or uncontrolled hypertension
• Participation in an investigational study within 60 days prior to receiving study medication
• Any clinically significant laboratory value at screening, including pre-existing electrolyte abnormality, based on clinical history that the Investigator feels may affect the study evaluation
• Hypersensitivity to any ingredient in the study medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: picosulfate,MgO, citric acid, bowel preparation, powder; colonoscopy picosulfate,MgO, citric acid, bowel preparation, powder	Drug: Picosulfate sodium, magnesium oxide, citric acid
Active Comparator: polyethylene glycol, bisacodyl,; colonoscopy polyethylene glycol,powder bisacodyl,tablet	Drug: Picosulfate sodium, magnesium oxide, citric acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.	six months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale.	six months

Collaborators and Investigators

• Sponsor: Universal Integrated Corp.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2013
• Primary Completion (Actual): March 24, 2014
• Study Completion (Actual): June 17, 2014

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 14, 2013

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 26, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anticoagulants; Chelating Agents; Sequestering Agents; Cathartics; Calcium Chelating Agents; Antacids; Picosulfate sodium; Magnesium Oxide; Citric Acid; Sodium Citrate
• Other Study ID Numbers: UIC-BKL-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided