To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
136
Solution for oral administration prior to colonoscopy
Solution for oral administration prior to colonoscopy
University of South Alabama
Mobile, Alabama, United States
Jupiter Research
Jupiter, Florida, United States
Miami Research Associates
Miami, Florida, United States
Indiana University Medical Center
Indianapolis, Indiana, United States
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.
Time frame: 2 days
Assessment of Residual Stool - Cecum
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
Assessment of Residual Stool - Ascending Colon
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
Assessment of Residual Stool - Transverse Colon
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
Assessment of Residual Stool - Descending Colon
The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 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.
Time frame: 2 days
Assessment of Residual Fluid - Cecum
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
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Long Island GI Research Group
Great Neck, New York, United States
Assessment of Residual Fluid - Ascending Colon
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
Assessment of Residual Fluid - Transverse Colon
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 2 days
Assessment of Residual Fluid - Descending Colon
The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: up to 15 days