A Safety and Efficacy Comparison of BLI4700 Bowel Prep Versus an FDA-approved Comparator in Adults Prior to Colonoscopy

• BLI4700 (Drug): Oral bowel preparation
• Polyethylene glycol bowel preparation (Drug): Oral bowel preparation

Primary outcomes

• Number and Percentage of Subjects With Successful Bowel Cleansing [Day of colonoscopy]: % of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)

Other outcomes

• Abdominal Distension (Solicited Reports) [2 days]: Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event
• Abdominal Pain (Solicited Reports) [2 days]: Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event
• Nausea (Solicited Reports) [2 days]: Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event
• Vomiting (Solicited Reports) [2 days]: Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event

Sex: All, ages: 18 Years to 85 Years

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.

Participant flow

Outcome results

• Number and Percentage of Subjects With Successful Bowel Cleansing (Primary), Count of participants, Participants: BLI4700 Bowel Preparation 257; FDA Approved Bowel Preparation 241 (p <0.001)
• Abdominal Distension (Solicited Reports) (Other pre specified), Number, percentage of patients: BLI4700 Bowel Preparation 68; FDA Approved Bowel Preparation 71
• Abdominal Pain (Solicited Reports) (Other pre specified), Number, percentage of patients: BLI4700 Bowel Preparation 65; FDA Approved Bowel Preparation 71
• Nausea (Solicited Reports) (Other pre specified), Number, percentage of patients: BLI4700 Bowel Preparation 71; FDA Approved Bowel Preparation 77
• Vomiting (Solicited Reports) (Other pre specified), Number, percentage of patients: BLI4700 Bowel Preparation 48; FDA Approved Bowel Preparation 46

Adverse events

Time frame: 30 days

Serious adverse events by term

Other adverse events by term

• Results publication: 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. PMID 33165006

• Study Protocol and Statistical Analysis Plan (PDF, 2018-04-05)

• John McGowan, MPH, Study director, Braintree Laboratories, Inc.