An Open-Label Preference Evaluation of BLI800

Braintree Laboratories

Status and phase: Completed; Phase 4

Conditions: Colonoscopy

Treatments: Drug: BLI800

Study type: Interventional

Funder types: Industry

Identifiers

NCT04214301

BLI800-491

Details and patient eligibility

About

The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.

Full description

The objective of this study is to evaluate the patient satisfaction and preference of BLI800 in adult patients undergoing colonoscopy.

Enrollment: 40 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary 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
• 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

Primary 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 known severe renal, hepatic or cardiac insufficiency
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

BLI800

Experimental group

Description:

BLI800

Treatment:

Drug: BLI800