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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2013 by Universal Integrated Corp..
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

Universal Integrated Corp.

ClinicalTrials.gov Identifier:

NCT01984008

First received: October 24, 2013

Last updated: May 31, 2015

Last verified: November 2013

History of Changes

Purpose

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).

Condition	Intervention	Phase
Bowel Preparation Before Colonoscopy	Drug: Picosulfate sodium, magnesium oxide, citric acid	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy

Drug Information available for: Sodium citrate Magnesium oxide Citric acid monohydrate Magnesium Sodium Picosulfate

U.S. FDA Resources

Further study details as provided by Universal Integrated Corp.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Estimated Enrollment:	600
Study Start Date:	October 2013
Estimated Study Completion Date:	July 2015
Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	20 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01984008

Locations


Taiwan
China Medical University Hospital
Taichung, Taiwan, 40447

Sponsors and Collaborators

Universal Integrated Corp.

More Information


Responsible Party:	Universal Integrated Corp.
ClinicalTrials.gov Identifier:	NCT01984008 History of Changes
Other Study ID Numbers:	UIC-BKL-2013
Study First Received:	October 24, 2013
Last Updated:	May 31, 2015

Additional relevant MeSH terms:


Citric Acid Picosulfate sodium Magnesium Oxide Anticoagulants Calcium Chelating Agents Chelating Agents	Sequestering Agents Molecular Mechanisms of Pharmacological Action Cathartics Gastrointestinal Agents Antacids

ClinicalTrials.gov processed this record on July 17, 2017

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