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

March 5, 2009
October 15, 2010
February 2009
May 2009   (final data collection date for primary outcome measure)
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.
Efficacy: preparation success based on a 4 point scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00856843 on ClinicalTrials.gov Archive Site
  • 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.
Safety: preparation related side effects, blood chemistry [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
BLI800-303: An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Colonoscopy
  • Drug: BLI800
    Solution for oral administration prior to colonoscopy
  • Drug: Polyethylene glycol 3350 based bowel preparation
    Solution for oral administration prior to colonoscopy
  • Active Comparator: Polyethylene glycol 3350 based bowel preparation
    Polyethylene glycol 3350 based bowel preparation
    Intervention: Drug: Polyethylene glycol 3350 based bowel preparation
  • Experimental: BLI800
    BLI800
    Intervention: Drug: BLI800
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. Epub 2010 Jun 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
Not Provided
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00856843
BLI800-303
No
John McGowan, Associate Director, Clinical Research, Braintree Laboratories, Inc.
Braintree Laboratories
Not Provided
Study Director: John McGowan, MPH Braintree Laboratories, Inc.
Braintree Laboratories
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP