BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
- Conditions
- Colonoscopy
- Interventions
- Drug: Polyethylene glycol 3350 based bowel preparation
- Registration Number
- NCT00856843
- Lead Sponsor
- Braintree Laboratories
- Brief Summary
To evaluate the safety and efficacy of BLI800 vs an FDA approved bowel preparation before colonoscopic examination in adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 136
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Polyethylene glycol 3350 based bowel preparation Polyethylene glycol 3350 based bowel preparation Polyethylene glycol 3350 based bowel preparation BLI800 BLI800 BLI800
- Primary Outcome Measures
Name Time Method Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale 2 days Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.
- Secondary Outcome Measures
Name Time Method Assessment of Residual Stool - Cecum 2 days The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Ascending Colon 2 days The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Transverse Colon 2 days The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Descending Colon 2 days The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Stool - Sigmoid Colon/Rectum 2 days The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Cecum 2 days The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Ascending Colon 2 days The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Transverse Colon 2 days The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Descending Colon 2 days The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Assessment of Residual Fluid - Sigmoid Colon/Rectum 2 days The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.
Subject Symptom Scores 2 days 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).
Mean Change in Serum Chemistry (mg/dL) up to 15 days 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.
Mean Change in Serum Chemistry (mEq/L) up to 15 days 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.
Trial Locations
- Locations (5)
Miami Research Associates
🇺🇸Miami, Florida, United States
Indiana University Medical Center
🇺🇸Indianapolis, Indiana, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Jupiter Research
🇺🇸Jupiter, Florida, United States
Long Island GI Research Group
🇺🇸Great Neck, New York, United States