BLI850-302: BLI850 vs an Approved 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:
NCT00756548
First received: September 18, 2008
Last updated: December 3, 2013
Last verified: December 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: BLI850-302: BLI850 vs an Approved 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 days ] [ Designated as safety issue: No ]
    Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent")


Secondary Outcome Measures:
  • Serum Chemistry Results (mEq/L) [ 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 (mg/dL) [ 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 - Glomerular Filtration Rate [ 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 (1000/MCL) [ 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: 386
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, intra-uterine device, 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: NCT00756548

Locations
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
Advanced Clinical Research Institute
Orange, California, United States, 92869
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Mississippi
Gastrointestinal Associates
Jackson, Mississippi, United States, 39202
United States, Oklahoma
Options Health Research
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Northwest Gastroenterology Clinic
Portland, Oregon, United States, 97210
United States, Tennessee
Franklin Gastroenterology
Franklin, Tennessee, United States, 37067
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
The Frist Clinic
Nashville, Tennessee, United States, 37203
United States, Texas
Houston Medical Research Associates
Houston, Texas, United States, 77090
United States, Virginia
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
United States, Washington
Northwest Gastroenterology Associates
Bellevue, Washington, United States, 98004
Sponsors and Collaborators
Braintree Laboratories
  More Information

No publications provided

Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00756548     History of Changes
Other Study ID Numbers: BLI850-302, BLI850-302
Study First Received: September 18, 2008
Results First Received: February 19, 2013
Last Updated: December 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Braintree Laboratories:
colonoscopy
screening

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 22, 2014