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

Colonoscopy Clinical Trial

Official title:

BLI4700-301: 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: NCT03404401
• Other study ID #: BLI4700-301
• Status: Completed
• Phase: Phase 3
• Start date: January 11, 2018
• Est. completion date: July 10, 2018

Study information

• Verified date: May 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: 620
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 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

• 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.

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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

Locations

Country	Name	City	State
United States	Braintree Research Site 209	Anaheim	California
United States	Braintree Research Site 224	Atlanta	Georgia
United States	Braintree Research Site 219	Chula Vista	California
United States	Braintree Research Site 214	Cincinnati	Ohio
United States	Braintree Research Site 216	Columbia	South Carolina
United States	Braintree Research Site 215	Decatur	Georgia
United States	Braintree Research Site 218	Flowood	Mississippi
United States	Braintree Research Site 202	Franklin	Tennessee
United States	Braintree Research Site 210	Great Neck	New York
United States	Braintree Research Site 207	Hagerstown	Maryland
United States	Braintree Research Site 221	Inverness	Florida
United States	Braintree Research Site 203	Jackson	Tennessee
United States	Braintree Research Site 222	Jacksonville	Florida
United States	Braintree Research Site 223	Lake Charles	Louisiana
United States	Braintree Research Site 206	Los Angeles	California
United States	Braintree Research Site 208	Milwaukee	Wisconsin
United States	Braintree Research Site 212	Mobile	Alabama
United States	Braintree Research Site 211	Monroe	Louisiana
United States	Braintree Research Site 217	Ogden	Utah
United States	Braintree Research Site 201	Palm Harbor	Florida
United States	Braintree Research Site 213	Portland	Oregon
United States	Braintree Research Site 220	San Diego	California
United States	Braintree Research Site 204	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 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	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	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