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OpenTrials
Completed

NCT Number: NCT00756548

BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Advanced Clinical Research Institute, Anaheim, California, 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, including:
  • Evaluation of barium enema results
  • GI bleeding
  • Anemia of unknown etiology
  • Neoplastic disease surveillance
  • Abnormal Endosonography
  • Inflammatory bowel disease
  • Unknown diarrhea or constipation etiology
  • Polypectomy
  • Laser therapy
  • Routine screening
  • 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 (hormonal birth control, intra-uterine device, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
  • 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 with impaired consciousness that predisposes them to pulmonary aspiration.
  • Subjects who are undergoing colonoscopy for foreign body removal or decompression.
  • Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
  • Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
  • Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  • Subjects of childbearing potential who refuse a pregnancy test.
  • Subjects who are 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

BLI850

Drug

multi-dose preparation for oral administration prior to colonoscopy

Polyethylene glycol 3350 based bowel preparation

Drug

multi-dose preparation for oral administration prior to colonoscopy

Primary outcomes

  1. Efficacy - Preparation Quality Using a 4 Point Scale

    Time frame: 2 days

    Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")

Secondary outcomes

  1. Serum Chemistry Results (mEq/L)

    Time frame: 2 days

    Change from Baseline

  2. Hematology Results (%)

    Time frame: 2 days

    Change from Baseline

  3. Serum Chemistry Results (U/L)

    Time frame: 2 days

    Change from Baseline

  4. Serum Chemistry Results (mg/dL)

    Time frame: 2 days

    Change from Baseline

  5. Serum Chemistry Results (g/dL)

    Time frame: 2 days

    Change from Baseline

  6. Serum Chemistry Results - Glomerular Filtration Rate

    Time frame: 2 days

    Change from Baseline

  7. Hematology Results - Hemoglobin

    Time frame: 2 days

    Change from Baseline

  8. Hematology Results (1000/MCL)

    Time frame: 2 days

    Change from Baseline

  9. Hematology Results - Red Blood Cells

    Time frame: 2 days

    Change from Baseline

  10. Serum Chemistry Results (Osmolality)

    Time frame: 2 days

    Change from Baseline

Sponsors and collaborators

Lead sponsor

Braintree Laboratories

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Sep 22, 2008
Registry last updated
Dec 27, 2013

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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