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A Pilot Evaluation of an Experimental BLI4600 Formulation for Bowel Preparation in Adult Patients Undergoing Colonoscopy

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: NCT02376465
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : July 19, 2016
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Brief Summary:
To evaluate the safety, tolerance and efficacy of BLI4600 in multiple dosing regimens as a bowel preparation prior to colonoscopy in adult patients.

Condition or disease Intervention/treatment Phase
Bowel Preparation for Colonoscopy Drug: BLI4600 bowel preparation Drug: PEG based bowel preparation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: BLI4600 Regimen 1
Oral bowel preparation for colonoscopy
Drug: BLI4600 bowel preparation
Oral bowel preparation for colonoscopy

Experimental: BLI4600 Regimen 2
Oral bowel preparation for colonoscopy
Drug: BLI4600 bowel preparation
Oral bowel preparation for colonoscopy

Active Comparator: PEG based below preparation
Oral bowel preparation for colonoscopy
Drug: PEG based bowel preparation
Oral bowel preparation for colonoscopy




Primary Outcome Measures :
  1. % of subjects with successful preparation on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent) [ Time Frame: 1 Day ]
    % of subjects with successful preparation by colonoscopist on a 4 point scale (1 = poor, 2 = fair, 3 = good, 4 = excellent)


Secondary Outcome Measures :
  1. Ottawa Bowel Preparation Scale Score [ Time Frame: 1 Day ]


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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).

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 (e.g. colostomy, colectomy, gastric bypass, stomach stapling).

Subjects with uncontrolled pre-existing electrolyte abnormalities, 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): NCT02376465


Locations
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United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
Sponsors and Collaborators
Braintree Laboratories
Investigators
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Study Director: John McGowan, MPH Braintree Laboratories, Inc.
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT02376465    
Other Study ID Numbers: BLI4600-201
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: July 19, 2016
Last Verified: July 2016