BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Study Overview
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Brief Summary
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To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.

Official Title
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BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Conditions
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Colonoscopy

Intervention / Treatment
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* Drug: BLI800
* 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. 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 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 gastrointestinal surgeries. Subjects with known or suspected electrolyte abnormalities such as hypernatremia, hyponatremia, hyperphosphatemia, hypokalemia, hypocalcemia, dehydration, or those secondary to the use of diuretics or angiotensin converting enzyme (ACE) inhibitors. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. 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 |
| --- | --- |
| Active Comparator: Polyethylene glycol 3350 based bowel preparation<br>Polyethylene glycol 3350 based bowel preparation | Drug: Polyethylene glycol 3350 based bowel preparation<br>* Solution for oral administration prior to colonoscopy<br>|
| Experimental: BLI800<br>BLI800 | Drug: BLI800<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 |
| --- | --- | --- |
| Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale | Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of Residual Stool - Cecum | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Stool - Ascending Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Stool - Transverse Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Stool - Descending Colon | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Stool - Sigmoid Colon/Rectum | The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Fluid - Cecum | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Fluid - Ascending Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Fluid - Transverse Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Fluid - Descending Colon | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Assessment of Residual Fluid - Sigmoid Colon/Rectum | The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess. | 2 days | 
| Subject Symptom Scores | Expected preparation related symptoms of Abdominal Cramping, Abdominal Bloating, Nausea and Overall discomfort were rated by each subject from 1 - 5 (1=none, 2=mild, 3=bothersome, 4=distressing, 5=severely distressing). | 2 days | 
| Mean Change in Serum Chemistry (mg/dL) | Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: blood urea nitrogen, calcium, creatinine, phosphorus. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw. | up to 15 days | 
| Mean Change in Serum Chemistry (mEq/L) | Mean changes from Baseline to Post-preparation for the following analytes will be compared between treatment groups: bicarbonate, chloride, magnesium, potassium, sodium. Baseline lab samples were allowed to be drawn within 15 days of the post-preparation (Visit 2) lab draw. | up to 15 days | 

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