An Open-Label Preference Evaluation of BLI800

Colonoscopy Clinical Trial

Official title:

An Open-Label Preference Evaluation of BLI800

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214301
• Other study ID #: BLI800-491
• Status: Completed
• Phase: Phase 4
• Start date: September 24, 2019
• Est. completion date: November 21, 2019

Study information

• Verified date: September 2023
• Source: Braintree Laboratories
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Drug:
• BLI800
BLI800 Bowel Preparation

Locations

Country	Name	City	State
United States	Braintree Research Site 2	Bellevue	Washington
United States	Braintree Research Site 1	Great Neck	New York

Sponsors (1)

Lead Sponsor	Collaborator
Braintree Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ease of Preparation Consumption	Question: How easy or difficult was it to consume the study preparation?	2 days
Secondary	Preparation Compliance	Question: Were you able to consume the entire preparation as instructed?	2 days
Secondary	Rating of Overall Experience		2 days
Secondary	Comparison to Prior Preparation	How did this preparation experience compare to your prior experience?	2 days
Secondary	Willingness to Repeat Preparation	Would you ask your doctor for this preparation again if you need another colonoscopy in the future?	2 days
Secondary	Refuse if Prescribed Again	Would you refuse the same preparation again if it were to be prescribed to you in the future?	2 days
Secondary	Rating of Aftertaste		2 days