An Open-Label Preference Evaluation of BLI800

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: BLI800

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Great Neck, New York, United States, 11023
      • Braintree Research Site 1
  • Washington
    • Bellevue, Washington, United States, 98004
      • Braintree Research Site 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI800	Drug: BLI800; BLI800 Bowel Preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of Preparation Consumption	Question: How easy or difficult was it to consume the study preparation?	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preparation Compliance	Question: Were you able to consume the entire preparation as instructed?	2 days
Rating of Overall Experience		2 days
Comparison to Prior Preparation	How did this preparation experience compare to your prior experience?	2 days
Willingness to Repeat Preparation	Would you ask your doctor for this preparation again if you need another colonoscopy in the future?	2 days
Refuse if Prescribed Again	Would you refuse the same preparation again if it were to be prescribed to you in the future?	2 days
Rating of Aftertaste		2 days

Collaborators and Investigators

• Sponsor: Braintree Laboratories
• Investigators: Study Director: John McGowan, MPH, Braintree Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2019
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): November 21, 2019

Study Registration Dates

• First Submitted: December 27, 2019
• First Submitted That Met QC Criteria: December 27, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: BLI800-491

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No