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Completed

NCT Number: NCT00856843

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of South Alabama, Mobile, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

BLI800

Drug

Solution for oral administration prior to colonoscopy

Polyethylene glycol 3350 based bowel preparation

Drug

Solution for oral administration prior to colonoscopy

Primary outcomes

  1. Efficacy: Percentage of Patients With Successful Preparations Based on a 4 Point Scale

    Time frame: 2 days

    Blinded colonoscopists rated cleansing quality as either Excellent, Good, Fair or Poor. Scores of Excellent or Good were considered Successful preparations.

Secondary outcomes

  1. Assessment of Residual Stool - Cecum

    Time frame: 2 days

    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  2. Assessment of Residual Stool - Ascending Colon

    Time frame: 2 days

    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  3. Assessment of Residual Stool - Transverse Colon

    Time frame: 2 days

    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  4. Assessment of Residual Stool - Descending Colon

    Time frame: 2 days

    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  5. Assessment of Residual Stool - Sigmoid Colon/Rectum

    Time frame: 2 days

    The blinded colonoscopist rated residual stool in specific colon sections as Absent, Small, Moderate or Excess.

  6. Assessment of Residual Fluid - Cecum

    Time frame: 2 days

    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  7. Assessment of Residual Fluid - Ascending Colon

    Time frame: 2 days

    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  8. Assessment of Residual Fluid - Transverse Colon

    Time frame: 2 days

    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  9. Assessment of Residual Fluid - Descending Colon

    Time frame: 2 days

    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  10. Assessment of Residual Fluid - Sigmoid Colon/Rectum

    Time frame: 2 days

    The blinded colonoscopist rated residual fluid in specific colon sections as Absent, Small, Moderate or Excess.

  11. Subject Symptom Scores

    Time frame: 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).

  12. Mean Change in Serum Chemistry (mg/dL)

    Time frame: 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.

  13. Mean Change in Serum Chemistry (mEq/L)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
First posted
Mar 6, 2009
Registry last updated
Nov 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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