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

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

Study Overview

• Status: Completed
• Conditions: Colonoscopy
• Intervention / Treatment: Drug: Polyethylene glycol 3350 based bowel preparation; Drug: BLI800

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36693
      • University of South Alabama
  • Florida
    • Jupiter, Florida, United States, 33458
      • Jupiter Research
    • Miami, Florida, United States, 33143
      • Miami Research Associates
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Medical Center
  • New York
    • Great Neck, New York, United States, 11023
      • Long Island GI Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. At least 18 years of age
3. Otherwise in good health, as determined by physical exam and medical history
4. If female, and of child-bearing potential, is using an acceptable form of birth control
5. Negative urine pregnancy test at screening, if applicable
6. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous gastrointestinal surgeries.
3. 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.
4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BLI800	Drug: BLI800; Solution for oral administration prior to colonoscopy
Active Comparator: Polyethylene glycol 3350 based bowel preparation	Drug: Polyethylene glycol 3350 based bowel preparation; Solution for oral administration prior to colonoscopy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Braintree Laboratories

Publications and helpful links

General Publications

• Rex DK, Di Palma JA, Rodriguez R, McGowan J, Cleveland M. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010 Aug;72(2):328-36. doi: 10.1016/j.gie.2010.03.1054. Epub 2010 Jun 19.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: March 5, 2009
• First Submitted That Met QC Criteria: March 5, 2009
• First Posted (Estimate): March 6, 2009

Study Record Updates

• Last Update Posted (Estimate): November 10, 2010
• Last Update Submitted That Met QC Criteria: October 15, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: colonoscopy; bowel preparation
• Additional Relevant MeSH Terms: Gastrointestinal Agents; Laxatives; Polyethylene glycol 3350
• Other Study ID Numbers: BLI800-303