A Safety Study of 3 Different Bowel Cleansing Preparations

Study Overview
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Brief Summary
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The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Official Title
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A Safety, Tolerance and Efficacy Evaluation of 3 Different Bowel Cleansing Preparations in Adult Subjects, Including the Elderly and Subjects With Hepatic or Renal Insufficiency

Conditions
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Colonoscopy, Bowel Preparation, Endoscopy

Intervention / Treatment
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* Drug: PEG-3350 based bowel preparation
* Drug: BLI800 approved preparation regimen
* Drug: BLI800 investigational preparation regimen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication. At least 18 years of age 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 Exclusion Criteria: Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon. Subjects who had previous significant gastrointestinal surgeries. Subjects who have uncontrolled clinically significant pre-existing electrolyte disturbances. Subjects with severe liver or renal insufficiency. Subjects with a history of congestive heart failure or other clinically significant cardiac abnormality. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. Subjects undergoing colonoscopy for foreign body removal and decompression. Subjects who are pregnant or lactating, or intending to become pregnant during the study. Subjects of childbearing potential who refuse a pregnancy test. Subjects allergic to any preparation components Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BLI800 approved preparation regimen<br>BLI800 approved preparation regimen | Drug: BLI800 approved preparation regimen<br>* solution for oral administration prior to colonoscopy<br>|
| Experimental: BLI800 investigational preparation regimen<br>BLI800 investigational preparation regimen | Drug: BLI800 investigational preparation regimen<br>* solution for oral administration prior to colonoscopy<br>|
| Active Comparator: PEG-3350 based bowel preparation<br>PEG-3350 based bowel preparation | Drug: PEG-3350 based bowel preparation<br>* solution for oral administration prior to colonoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of adverse events |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % of subjects with successful preparation | rated by blinded colonoscopist on 4 point scale (1 = poor to 4 = excellent) | Day of colonoscopy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, bowel preparation, endoscopy