An Open-Label Preference Evaluation of BLI800

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

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

Official Title
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An Open-Label Preference Evaluation of BLI800

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: BLI800


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI800<br>BLI800 | Drug: BLI800<br>* BLI800 Bowel Preparation<br>|

What is the study measuring?
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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 |