Phase 4
N=40
An Open-Label Preference Evaluation of BLI800
Colonoscopy
Bottom Line
View on ClinicalTrials.gov: NCT04214301 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcome: Primary: Ease of Preparation Consumption — 3; 5; 15; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- BLI800 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Braintree Laboratories
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ease of Preparation Consumption |
3; 5; 15; 7; 8 | — |
| SECONDARY Preparation Compliance |
36; 2 | — |
| SECONDARY Rating of Overall Experience |
9; 20; 6; 3; 0 | — |
| SECONDARY Comparison to Prior Preparation |
2; 8; 12 | — |
| SECONDARY Willingness to Repeat Preparation |
30; 8 | — |
| SECONDARY Refuse if Prescribed Again |
5; 33 | — |
| SECONDARY Rating of Aftertaste |
1; 6; 15; 11; 5 | — |
Summary
The purpose of this study is to evaluate patient experience ratings of BLI800 in adult patients undergoing colonoscopy.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT04214301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.