An Open-Label Preference Evaluation of BLI800

Phase 4

Completed

• Conditions: Colonoscopy
• Interventions: Drug: BLI800

• Registration Number: NCT04214301
• Lead Sponsor: Braintree Laboratories

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2019-09-24
• Primary Completion: 2019-11-21
• Study Completion: 2019-11-21
• Study First Submitted: 2019-12-27
• Study First Submitted QC: 2019-12-27
• Study First Posted: 2020-01-02
• Status Verified: 2023-09
• Results First Submitted: 2023-09-25
• Results First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Results First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BLI800	BLI800	BLI800

Primary Outcome Measures

Name	Time	Method
Ease of Preparation Consumption	2 days	Question: How easy or difficult was it to consume the study preparation?

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Braintree Research Site 1; 🇺🇸 Great Neck, New York, United States

Braintree Research Site 2; 🇺🇸 Bellevue, Washington, United States