A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Colonoscopy Clinical Trial

Official title:

A Safety and Efficacy Comparison of BLI4700 Bowel Preparation Versus an FDA-approved Comparator in Adult Subjects Prior to Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261960
• Other study ID #: BLI4700-302
• Status: Completed
• Phase: Phase 3
• Start date: August 8, 2017
• Est. completion date: March 26, 2018

Study information

• Verified date: August 2021
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

• 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 and 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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• BLI4700
Oral bowel preparation
• Magnesium bowel preparation
Oral bowel preparation

Locations

Country	Name	City	State
United States	Braintree Research Site 105	Asheville	North Carolina
United States	Braintree Research Site 121	Bellevue	Washington
United States	Braintree Research Site 115	Charlotte	North Carolina
United States	Braintree Research Site 131	Charlottesville	Virginia
United States	Braintree Research Site 125	Chesterfield	Missouri
United States	Braintree Research Site 112	Chevy Chase	Maryland
United States	Braintree Research Site 119	Dothan	Alabama
United States	Braintree Research Site 145	Egg Harbor Township	New Jersey
United States	Braintree Research Site 107	Greenville	South Carolina
United States	Braintree Research Site 134	Indianapolis	Indiana
United States	Braintree Research Site 108	Little Rock	Arkansas
United States	Braintree Research Site 110	Little Rock	Arkansas
United States	Braintree Research Site 124	Oak Lawn	Illinois
United States	Braintree Research Site 139	Palmetto Bay	Florida
United States	Braintree Research Site 114	Poughkeepsie	New York
United States	Braintree Research Site 101	Raleigh	North Carolina
United States	Braintree Research Site 137	Raleigh	North Carolina
United States	Braintree Research Site 102	Saint Louis	Missouri
United States	Braintree Research Site 141	Towson	Maryland
United States	Braintree Research Site 117	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Abdominal Pain (Solicited Reports)	Percentage of patients who reported abdominal pain (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Other	Abdominal Distension (Solicited Reports)	Percentage of patients who reported abdominal distension (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Other	Nausea (Solicited Reports)	Percentage of patients who reported nausea (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Other	Vomiting (Solicited Reports)	Percentage of patients who reported vomiting (with associated severity) when directly queried by study personnel, out of all patients that reported that event.	2 days
Primary	Number and Percentage of Subjects With Successful Bowel Cleansing	% of subjects with successful bowel preparation rated by colonoscopist on a 4 point scale (1=poor to 4=excellent)	Day of colonoscopy