A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

Braintree Laboratories

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colonoscopy

Treatments: Drug: BLI4700

Study type: Interventional

Funder types: Industry

Identifiers

NCT03023085

BLI4700-201

Details and patient eligibility

About

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. Have previously had a colonoscopy performed
3. At least 18 years of age
4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
5. If female, and of child-bearing potential, is using an acceptable form of birth control.
6. Negative urine pregnancy test at screening, if applicable
7. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Key Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

BLI4700

Experimental group

Description:

BLI4700 Bowel Preparation

Treatment:

Drug: BLI4700