BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Study Overview
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Brief Summary
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This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Official Title
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BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Conditions
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Colon Cancer

Intervention / Treatment
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* Drug: BLI850
* Drug: polyethylene glycol 3350 based bowel preparation


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, including: Evaluation of barium enema results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Abnormal Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine screening At least 18 years of age. Otherwise in good health, as determined by physical exam and medical history. If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, intra-uterine device, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse). 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 with impaired consciousness that predisposes them to pulmonary aspiration. Subjects who are undergoing colonoscopy for foreign body removal or decompression. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass). Subjects who are pregnant or lactating, or intending to become pregnant during the study. Subjects of childbearing potential who refuse a pregnancy test. Subjects who are 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: 1<br>multi-dose preparation for oral administration prior to colonoscopy | Drug: BLI850<br>* multi-dose preparation for oral administration prior to colonoscopy<br>|
| Active Comparator: 2<br>multi-dose preparation for oral administration prior to colonoscopy | Drug: polyethylene glycol 3350 based bowel preparation<br>* multi-dose preparation 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 |
| --- | --- | --- |
| Efficacy - Preparation Quality Using a 4 Point Scale | Percentage of patients with a successful preparation (cleaning rated as Good or Excellent) | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Chemistry Results (mEq/L) | Change from Baseline | 2 days | 
| Hematology Results (%) | Change from Baseline | 2 days | 
| Serum Chemistry Results (U/L) | Change from Baseline | 2 days | 
| Serum Chemistry Results (mg/dL) | Change from Baseline | 2 days | 
| Serum Chemistry Results (g/dL) | Change from Baseline | 2 days | 
| Serum Chemistry Results - Glomerular Filtration Rate | Change from Baseline | 2 days | 
| Hematology Results - Hemoglobin | Change from Baseline | 2 days | 
| Hematology Results (1000/MCL) | Change from Baseline | 2 days | 
| Hematology Results - Red Blood Cells | Change from Baseline | 2 days | 
| Serum Chemistry Results (Osmolality) | Change from Baseline | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, screening