A Pilot Evaluation of BLI4900 Bowel Preparation in Adult Subjects

Completed · Phase 2

Conditions studied: Colonoscopy

In brief

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

Key facts

Study ID

NCT03328507

Run by

Braintree Laboratories

People needed

121

Starts

2017-11-09

Expected to finish

2019-11-12

Last updated by the study team

2023-10-24

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Braintree Research Site 1 — Anaheim, California, United States
• Braintree Research Site 3 — Chula Vista, California, United States
• Braintree Research Site 4 — San Diego, California, United States
• Braintree Clinical Research Site 2 — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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