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

This study has been completed.
Sponsor:
Information provided by:
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00856843
First received: March 5, 2009
Last updated: October 15, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Colonoscopy
Drug: BLI800
Drug: Polyethylene glycol 3350 based bowel preparation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.


Secondary Outcome Measures:
  • Assessment of Residual Stool - Cecum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Stool - Ascending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Stool - Transverse Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Stool - Descending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Stool - Sigmoid Colon/Rectum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Fluid - Cecum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Fluid - Ascending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Fluid - Transverse Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Fluid - Descending Colon [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  • Assessment of Residual Fluid - Sigmoid Colon/Rectum [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  • Subject Symptom Scores [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: up to 15 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 136
Study Start Date: February 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polyethylene glycol 3350 based bowel preparation
Polyethylene glycol 3350 based bowel preparation
Drug: Polyethylene glycol 3350 based bowel preparation
Solution for oral administration prior to colonoscopy
Experimental: BLI800
BLI800
Drug: BLI800
Solution for oral administration prior to colonoscopy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856843

Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36693
United States, Florida
Jupiter Research
Jupiter, Florida, United States, 33458
Miami Research Associates
Miami, Florida, United States, 33143
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, New York
Long Island GI Research Group
Great Neck, New York, United States, 11023
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
  More Information

No publications provided by Braintree Laboratories

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00856843     History of Changes
Other Study ID Numbers: BLI800-303
Study First Received: March 5, 2009
Results First Received: September 3, 2010
Last Updated: October 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
colonoscopy
bowel preparation

ClinicalTrials.gov processed this record on April 16, 2014