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 |
The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel
preparation prior to colonoscopy in adult patients.
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
Click here to add this to my saved trials
Click here to add this to my saved trials