Clinical trial NCT04446299: Study 301: BLI4900 Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Official title: A Safety and Efficacy Comparison of BLI4900 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colonoscopy
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 519
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of BLI4900 bowel preparation to an FDA-approved control as 2-day, split-dose bowel preparations prior to colonoscopy in adult patients.


Eligibility criteria: Inclusion Criteria:

* Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
* 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 known or suspected ileus, gastrointestinal obstruction, gastroparesis, gastric retention, bowel perforation, toxic colitis or megacolon.
* 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.

Primary outcomes:
measure: Proportion of Subjects With Successful Bowel Preparation
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: 301 Research Site 18
state: Alabama
city: Sun City
country: United States
facility: 301 Research Site 24
state: Arizona
city: San Diego
country: United States
facility: 301 Research Site 7
state: California
city: Clearwater
country: United States
facility: 301 Research Site 16
state: Florida
city: Jacksonville
country: United States
facility: 301 Research Site 12
state: Florida
city: Palm Harbor
country: United States
facility: 301 Research Site 9
state: Florida
city: Palmetto Bay
country: United States
facility: 301 Research Site 4
state: Florida
city: Port Orange
country: United States
facility: 301 Research Site 26
state: Florida
city: Saint Petersburg
country: United States
facility: 301 Research Site 14
state: Florida
city: Sunrise
country: United States
facility: 301 Research Site 25
state: Florida
city: Decatur
country: United States
facility: 301 Research Site 2
state: Georgia
city: Indianapolis
country: United States
facility: 301 Research Site 10
state: Indiana
city: Monroe
country: United States
facility: 301 Research Site 3
state: Louisiana
city: Shreveport
country: United States
facility: 301 Research Site 17
state: Louisiana
city: Flowood
country: United States
facility: 301 Research Site 11
state: Mississippi
city: Chesterfield
country: United States
facility: 301 Research Site 13
state: Missouri
city: Reno
country: United States
facility: 301 Research Site 19
state: Nevada
city: Brooklyn
country: United States
facility: 301 Research Site 15
state: New York
city: Great Neck
country: United States
facility: 301 Research Site 5
state: New York
city: New York
country: United States
facility: 301 Research Site 23
state: New York
city: Raleigh
country: United States
facility: 301 Research Site 6
state: North Carolina
city: Mentor
country: United States
facility: 301 Research Site 21
state: Ohio
city: Hixson
country: United States
facility: 301 Research Site 20
state: Tennessee
city: Ogden
country: United States
facility: 301 Research Site 1
state: Utah
city: Milwaukee
country: United States
facility: 301 Research Site 22
state: Wisconsin
Study officials:
affiliation: Braintree Laboratories / Sebela Pharmaceuticals
name: John McGowan
role: STUDY_DIRECTOR
References: