A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 85
Updated:3/8/2019
Start Date:November 9, 2017
End Date:May 2019
Contact:John McGowan, MPH
Email:jmcgowan@braintreelabs.com
Phone:781-843-2202

Use our guide to learn which trials are right for you!

The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel
preparation prior to colonoscopy in adult patients.


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 urine 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, severe ulcerative colitis, gastrointestinal
obstruction, 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 with uncontrolled hypertension (systolic blood pressure > 170 mmHg and
diastolic blood pressure > 100 mmHg).

- 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 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 components.

- 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.

- Subjects who withdraw consent before completion of Visit 1 procedures.
We found this trial at
2
sites
Anaheim, California 92801
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
?
mi
from
Ogden, UT
Click here to add this to my saved trials