An Open-Label Preference Evaluation of BLI800
1 other identifier
interventional
40
1 country
2
Brief Summary
The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2019
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2019
CompletedFirst Submitted
Initial submission to the registry
December 27, 2019
CompletedFirst Posted
Study publicly available on registry
January 2, 2020
CompletedResults Posted
Study results publicly available
October 23, 2023
CompletedOctober 23, 2023
September 1, 2023
2 months
December 27, 2019
September 25, 2023
September 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Ease of Preparation Consumption
Question: How easy or difficult was it to consume the study preparation?
2 days
Secondary Outcomes (6)
Preparation Compliance
2 days
Rating of Overall Experience
2 days
Comparison to Prior Preparation
2 days
Willingness to Repeat Preparation
2 days
Refuse if Prescribed Again
2 days
- +1 more secondary outcomes
Study Arms (1)
BLI800
EXPERIMENTALBLI800
Interventions
Eligibility Criteria
You may qualify if:
- Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Braintree Research Site 1
Great Neck, New York, 11023, United States
Braintree Research Site 2
Bellevue, Washington, 98004, United States
Results Point of Contact
- Title
- Head of R&D, Gastroenterology
- Organization
- Braintree Laboratories, Inc.
Study Officials
- STUDY DIRECTOR
John Mcgowan, MPH
Braintree Laboratories, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2019
First Posted
January 2, 2020
Study Start
September 24, 2019
Primary Completion
November 21, 2019
Study Completion
November 21, 2019
Last Updated
October 23, 2023
Results First Posted
October 23, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share