Study 302: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
NCT ID: NCT04446312
Last Updated: 2023-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
500 participants
INTERVENTIONAL
2020-07-13
2021-02-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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BLI4900
Experimental bowel preparation solution for oral ingestion
Bowel Prep
Orally ingested liquid bowel preparation
FDA Approved Control
FDA approved bowel preparation solution for oral ingestion
Bowel Prep
Orally ingested liquid bowel preparation
Interventions
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Bowel Prep
Orally ingested liquid bowel preparation
Eligibility Criteria
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Inclusion Criteria
* 18 to 85 years of age (inclusive)
* If female, and of child-bearing potential, is using an acceptable form of birth control.
* Negative serum 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 inflammatory bowel disease who have a history of any bowel resection (small intestine or colon), suspected active inflammation, or symptoms suggestive of obstruction or known bowel stricture.
* Subjects who had previous significant gastrointestinal surgeries.
* Subjects who have regularly used laxatives or colon motility altering drugs in the last month (i.e. more than 2-3 times per week) and/or laxative use within 72 hours prior to administration of the preparation
* Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
* Subjects taking diuretics, anti-hypertensive medications, including angiotensin converting enzyme (ACE) inhibitors and Angiotensin II receptor blockers (ARBs), or chronic NSAIDs, that have not been stable for 30 days.
* Subjects with uncontrolled hypertension.
* Subjects taking antibiotics within 7 days of colonoscopy.
* Subjects with severe renal, hepatic or cardiac insufficiency.
* Subjects with an abnormal and clinically significant physical examination or ECG finding at Visit 1.
* Subjects undergoing insulin therapy for any indication.
* Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
* Subjects undergoing colonoscopy for foreign body removal and/or decompression.
* Subjects taking tricyclic antidepressants.
* Subjects using drugs of abuse, including abused prescription medications.
* Subjects who are withdrawing from alcohol or benzodiazepines.
18 Years
85 Years
ALL
No
Sponsors
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Braintree Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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John McGowan
Role: STUDY_DIRECTOR
Braintree Laboratories / Sebela Pharmaceuticals
Locations
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302 Research Site 2
Tucson, Arizona, United States
302 Research Site 10
Little Rock, Arkansas, United States
302 Research Site 11
North Little Rock, Arkansas, United States
302 Research Site 9
Chula Vista, California, United States
302 Research Site 31
Los Angeles, California, United States
302 Research Site 22
Bristol, Connecticut, United States
302 Research Site 17
Fleming Island, Florida, United States
302 Research Site 3
Inverness, Florida, United States
302 Research Site 14
Jacksonville, Florida, United States
302 Research Site 28
Miami, Florida, United States
302 Research Site 29
Miami, Florida, United States
302 Research Site 30
Miami, Florida, United States
302 Research Site 38
Palm Harbor, Florida, United States
302 Research Site 5
Oak Lawn, Illinois, United States
302 Research Site 34
Baton Rouge, Louisiana, United States
302 Research Site 26
Mandeville, Louisiana, United States
302 Research Site 36
Monroe, Louisiana, United States
302 Research Site 16
Hagerstown, Maryland, United States
302 Research Site 39
Brooklyn, New York, United States
302 Research Site 37
Great Neck, New York, United States
302 Research Site 8
Asheville, North Carolina, United States
302 Research Site 25
High Point, North Carolina, United States
302 Research Site 1
Raleigh, North Carolina, United States
302 Research Site 13
Wilmington, North Carolina, United States
302 Research Site 18
Cincinnati, Ohio, United States
302 Research Site 23
Jackson, Tennessee, United States
302 Research Site 33
Kingsport, Tennessee, United States
302 Research Site 32
Cedar Park, Texas, United States
302 Research Site 21
Houston, Texas, United States
302 Research Site 35
Southlake, Texas, United States
302 Research Site 27
Webster, Texas, United States
302 Research Site 6
Charlottesville, Virginia, United States
302 Research Site 4
Fairfax, Virginia, United States
302 Research Site 7
Bellevue, Washington, United States
Countries
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References
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Bhandari R, Goldstein M, Mishkin DS, McGowan J, Cleveland MV, Di Palma JA. Comparison of a Novel, Flavor-optimized, Polyethylene Glycol and Sulfate Bowel Preparation With Oral Sulfate Solution in Adults Undergoing Colonoscopy. J Clin Gastroenterol. 2023 Oct 1;57(9):920-927. doi: 10.1097/MCG.0000000000001894.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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BLI4900-302
Identifier Type: -
Identifier Source: org_study_id
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