Status:
COMPLETED
A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects
Lead Sponsor:
Braintree Laboratories
Conditions:
Colonoscopy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety and efficacy of BLI4900 as a bowel preparation prior to colonoscopy in adult patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 12 2019
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03328507
Start Date
November 9 2017
End Date
November 12 2019
Last Update
October 24 2023
Active Locations (4)
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1
Braintree Research Site 1
Anaheim, California, United States, 92801
2
Braintree Research Site 3
Chula Vista, California, United States, 91910
3
Braintree Research Site 4
San Diego, California, United States, 92114
4
Braintree Clinical Research Site 2
Ogden, Utah, United States, 84405