Clinical trial NCT03404401: A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy
Official title: BLI4700-301: A Safety and Efficacy Comparison of BLI4700 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: 2018-01-19
Enrollment: 620
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 objective of this study is to compare the safety and efficacy of BLI4700 bowel preparation to an FDA-approved bowel preparation 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 ongoing severe, acute inflammatory bowel disease
* Subjects who had previous significant gastrointestinal surgeries.
* 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. NSAID use for occasional pain is not exclusionary.
* Subjects with uncontrolled hypertension (systolic blood pressure \> 170 mmHg or diastolic blood pressure \> 100 mmHg).
* Subjects taking antibiotics within 7 days of colonoscopy.
* Subjects with severe renal insufficiency (GFR \< 30 mL/min/1.73m2).
* Subjects with known severe hepatic insufficiency (Child Pugh C)
* Subjects with cardiac insufficiency (NYHA Functional Classifications 3 or 4).
* 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 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 component.
* Subjects using drugs of abuse, including abused prescription medications.
* Subjects who are withdrawing from alcohol or benzodiazepines.
* 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.

Primary outcomes:
measure: Number and Percentage of Subjects With Successful Bowel Cleansing
timeFrame: Day of colonoscopy
Secondary outcomes:
Other outcomes:
measure: Abdominal Distension (Solicited Reports)
timeFrame: 2 days
measure: Abdominal Pain (Solicited Reports)
timeFrame: 2 days
measure: Nausea (Solicited Reports)
timeFrame: 2 days
measure: Vomiting (Solicited Reports)
timeFrame: 2 days
Locations:
city: Mobile
country: United States
facility: Braintree Research Site 212
state: Alabama
city: Tucson
country: United States
facility: Braintree Research Site 204
state: Arizona
city: Anaheim
country: United States
facility: Braintree Research Site 209
state: California
city: Chula Vista
country: United States
facility: Braintree Research Site 219
state: California
city: Los Angeles
country: United States
facility: Braintree Research Site 206
state: California
city: San Diego
country: United States
facility: Braintree Research Site 220
state: California
city: Inverness
country: United States
facility: Braintree Research Site 221
state: Florida
city: Jacksonville
country: United States
facility: Braintree Research Site 222
state: Florida
city: Palm Harbor
country: United States
facility: Braintree Research Site 201
state: Florida
city: Atlanta
country: United States
facility: Braintree Research Site 224
state: Georgia
city: Decatur
country: United States
facility: Braintree Research Site 215
state: Georgia
city: Lake Charles
country: United States
facility: Braintree Research Site 223
state: Louisiana
city: Monroe
country: United States
facility: Braintree Research Site 211
state: Louisiana
city: Hagerstown
country: United States
facility: Braintree Research Site 207
state: Maryland
city: Flowood
country: United States
facility: Braintree Research Site 218
state: Mississippi
city: Great Neck
country: United States
facility: Braintree Research Site 210
state: New York
city: Cincinnati
country: United States
facility: Braintree Research Site 214
state: Ohio
city: Portland
country: United States
facility: Braintree Research Site 213
state: Oregon
city: Columbia
country: United States
facility: Braintree Research Site 216
state: South Carolina
city: Franklin
country: United States
facility: Braintree Research Site 202
state: Tennessee
city: Jackson
country: United States
facility: Braintree Research Site 203
state: Tennessee
city: Ogden
country: United States
facility: Braintree Research Site 217
state: Utah
city: Milwaukee
country: United States
facility: Braintree Research Site 208
state: Wisconsin
Study officials:
affiliation: Braintree Laboratories, Inc.
name: John McGowan, MPH
role: STUDY_DIRECTOR
References:
citation: Di Palma JA, Bhandari R, Cleveland MV, Mishkin DS, Tesoriero J, Hall S, McGowan J. A Safety and Efficacy Comparison of a New Sulfate-Based Tablet Bowel Preparation Versus a PEG and Ascorbate Comparator in Adult Subjects Undergoing Colonoscopy. Am J Gastroenterol. 2021 Feb 1;116(2):319-328. doi: 10.14309/ajg.0000000000001020.