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BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01786629
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : August 6, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
To compare the safety, tolerance and efficacy of SUPREP Bowel Prep Kit to an FDA approved control as bowel preparations prior to colonoscopy in adult patients.

Condition or disease Intervention/treatment Phase
Colonoscopy Bowel Preparation Endoscopy Drug: SUPREP Bowel Prep Kit Drug: FDA approved bowel preparation containing electrolytes Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 338 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BLI800-480: A Safety and Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Study Start Date : December 2012
Actual Primary Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
Drug Information available for: Suprep

Arm Intervention/treatment
Experimental: SUPREP Bowel Prep Kit
SUPREP Bowel Prep Kit
Drug: SUPREP Bowel Prep Kit
solution for oral administration prior to colonoscopy

Active Comparator: FDA approved bowel preparation
FDA approved bowel preparation containing electrolytes
Drug: FDA approved bowel preparation containing electrolytes
solution for oral administration prior to colonoscopy




Primary Outcome Measures :
  1. Percentage of Subjects With a Successful Preparation (Cleaning Rated as "Good" or "Excellent") [ Time Frame: Day of colonoscopy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.

At least 18 years of age

If female, and of child-bearing potential, is using an acceptable form of birth control

Negative urine pregnancy test at screening, if applicable

In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.

Subjects who had previous significant gastrointestinal surgeries

Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on screening laboratory results, such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors.

Subjects with a prior history of renal, liver or cardiac insufficiency

Subjects with impaired consciousness that predisposes them to pulmonary aspiration.

Subjects undergoing colonoscopy for foreign body removal and/or decompression.

Subjects who are pregnant or lactating, or intending to become pregnant during the study.

Subjects of childbearing potential who refuse a pregnancy test.

Subjects allergic to any preparation components.

Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.

Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Subjects who withdraw consent before completion of Visit 1 procedures.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01786629


Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Commonwealth Clinical Studies
Brockton, Massachusetts, United States, 02302
United States, Mississippi
Gastrointestinal Associates
Jackson, Mississippi, United States, 39202
United States, New York
Long Island GI Research Group
Great Neck, New York, United States, 11023
United States, North Carolina
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Oregon
Northwest Gastroenterology Clinic
Portland, Oregon, United States, 97210
United States, Tennessee
Franklin Gastroenterology
Franklin, Tennessee, United States, 37067
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Study Director: John McGowan, MPH Braintree Laboratories, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT01786629    
Other Study ID Numbers: BLI800-480
First Posted: February 8, 2013    Key Record Dates
Results First Posted: August 6, 2014
Last Update Posted: August 8, 2014
Last Verified: August 2014