BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories
ClinicalTrials.gov Identifier:
NCT00756977
First received: September 18, 2008
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Colon Cancer
Drug: BLI850
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: BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy

Resource links provided by NLM:


Further study details as provided by Braintree Laboratories:

Primary Outcome Measures:
  • Efficacy - Preparation Quality Using a 4 Point Scale [ Time Frame: 2-day ] [ Designated as safety issue: No ]
    Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"


Secondary Outcome Measures:
  • Serum Chemistry Results (mg/dL) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Hematology Results (%) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Serum Chemistry Results (U/L) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Serum Chemistry Results (mEq/L) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Serum Chemistry Results (g/dL) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Serum Chemistry Results (GFR) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Hematology Results (1000/MCL) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Hematology Results - Hemoglobin [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Hematology Results - Red Blood Cells [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline

  • Serum Chemistry Results (Osmolality) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    Change from Baseline


Enrollment: 394
Study Start Date: August 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
multi-dose preparation for oral administration prior to colonoscopy
Drug: BLI850
multi-dose preparation for oral administration prior to colonoscopy
Active Comparator: 2
multi-dose preparation for oral administration prior to colonoscopy
Drug: polyethylene glycol 3350 based bowel preparation
multi-dose preparation 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, 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
  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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, abstinent, or vasectomized spouse).
  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 with impaired consciousness that predisposes them to pulmonary aspiration.
  3. Subjects who are undergoing colonoscopy for foreign body removal or decompression.
  4. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
  5. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass).
  6. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
  7. Subjects of childbearing potential who refuse a pregnancy test.
  8. Subjects who are allergic to any preparation components
  9. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
  10. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00756977

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 Medical Research
New Smyrna Beach, Florida, United States, 32168
United States, Georgia
Atlanta Gastroenterology Associates
Roswell, Georgia, United States, 30076
United States, Louisiana
Delta Research Partners
Monroe, Louisiana, United States, 71201
United States, Maryland
Maryland Digestive Disease Research
Laurel, Maryland, United States, 20707
United States, New York
Long Island GI Research Group
Great Neck, New York, United States, 11023
United States, North Carolina
Carolina Digestive Health Associates
Harrisburg, North Carolina, United States, 28075
Wake Research Associates
Raleigh, North Carolina, United States, 27612
United States, Pennsylvania
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604
United States, Tennessee
Southeastern Clinical Research
Chattanooga, Tennessee, United States, 37403
Sponsors and Collaborators
Braintree Laboratories
Investigators
Study Director: John D McGowan Braintree Laboratories
  More Information

No publications provided

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00756977     History of Changes
Other Study ID Numbers: BLI850-301, BLI850-301
Study First Received: September 18, 2008
Results First Received: February 19, 2013
Last Updated: August 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
Colonoscopy
screening

ClinicalTrials.gov processed this record on September 18, 2014