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

NCT01984008 | Completed Phase 3

• 1 other identifier: UIC-BKL-2013
• Study Type: interventional
• Target: 631
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bowel Preparation Before Colonoscopy

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects that achieve excellent or good cleansing (success rate) in the Aronchick Scale.

  six months

Secondary Outcomes (1)

• Proportion of successes (excellent, good, or fair) by individual colon segment (ascending, transverse, descending), which are assessed with the Ottawa scale.

  six months

Study Arms (2)

picosulfate,MgO, citric acid, bowel preparation, powder

EXPERIMENTAL

colonoscopy picosulfate,MgO, citric acid, bowel preparation, powder

Drug: Picosulfate sodium, magnesium oxide, citric acid

polyethylene glycol, bisacodyl,

ACTIVE COMPARATOR

colonoscopy polyethylene glycol,powder bisacodyl,tablet

Drug: Picosulfate sodium, magnesium oxide, citric acid

Interventions

Picosulfate sodium, magnesium oxide, citric acid DRUG

picosulfate,MgO, citric acid, bowel preparation, powder; polyethylene glycol, bisacodyl,

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universal Integrated Corp.: lead

Study Sites (1)

China Medical University Hospital

Taichung, 40447, Taiwan

Location

MeSH Terms

Interventions

picosulfate sodium; Magnesium Oxide; Citric Acid

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: November 14, 2013
• Study Start: October 23, 2013
• Primary Completion: March 24, 2014
• Study Completion: June 17, 2014
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

TW (1)