A Safety Study of 3 Different Bowel Cleansing Preparations - Full Text View

Purpose

The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Condition	Intervention	Phase
Colonoscopy Bowel Preparation Endoscopy	Drug: PEG-3350 based bowel preparation Drug: BLI800 approved preparation regimen Drug: BLI800 investigational preparation regimen	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency

Resource links provided by NLM:

MedlinePlus related topics: Colonoscopy Endoscopy

U.S. FDA Resources

Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:

Frequency of adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

% of subjects with successful preparation [ Time Frame: Day of colonoscopy ] [ Designated as safety issue: No ]
rated by blinded colonoscopist on 4 point scale (1 = poor to 4 = excellent)

Estimated Enrollment:	540
Study Start Date:	December 2011
Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: BLI800 approved preparation regimen BLI800 approved preparation regimen	Drug: BLI800 approved preparation regimen solution for oral administration prior to colonoscopy
Experimental: BLI800 investigational preparation regimen BLI800 investigational preparation regimen	Drug: BLI800 investigational preparation regimen solution for oral administration prior to colonoscopy
Active Comparator: PEG-3350 based bowel preparation PEG-3350 based bowel preparation	Drug: PEG-3350 based bowel preparation solution for oral administration prior to colonoscopy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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 who have uncontrolled clinically significant pre-existing electrolyte disturbances.
Subjects with severe liver or renal insufficiency.
Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality.
Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
Subjects undergoing colonoscopy for foreign body removal and 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01501513

Locations

United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
United States, Florida
Borland-Groover Clinic
Jacksonville, Florida, United States, 32256
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Miami Research Associates
South Miami, Florida, United States, 33143
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Delta Research Partners
Monroe, Louisiana, United States, 71201
United States, Massachusetts
Commonwealth Clinical Studies
Brockton, Massachusetts, United States, 02302
United States, Mississippi
Gastrointestinal Associates
Jackson, Mississippi, United States, 39202
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
Carolina Digestive Health Associates
Charlotte, North Carolina, United States, 28262
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
United States, Oregon
Northwest Gastroenterology
Portland, Oregon, United States, 97210
United States, Tennessee
ClinSearch
Chattanooga, Tennessee, United States, 37421
Franklin Gastroenterology
Franklin, Tennessee, United States, 37067
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911

Sponsors and Collaborators

Braintree Laboratories

More Information

No publications provided

Responsible Party:	Braintree Laboratories
ClinicalTrials.gov Identifier:	NCT01501513 History of Changes
Other Study ID Numbers:	BLI800-440
Study First Received:	December 22, 2011
Last Updated:	May 2, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:

colonoscopy
bowel preparation
endoscopy

Additional relevant MeSH terms:

Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013