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

August 9, 2013 updated by: Braintree Laboratories
This is a randomized, parallel, multi-center, single-blind study, comparing BLI850 to an FDA approved bowel preparation in adult subjects undergoing colonoscopy.

Study Overview

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Mobile, Alabama, United States, 36693
        • University of South Alabama
    • Florida
      • Jupiter, Florida, United States, 33458
        • Jupiter Research
      • Miami, Florida, United States, 33143
        • Miami Research Associates
      • New Smyrna Beach, Florida, United States, 32168
        • United Medical Research
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Atlanta Gastroenterology Associates
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners
    • Maryland
      • Laurel, Maryland, United States, 20707
        • Maryland Digestive Disease Research
    • New York
      • Great Neck, New York, United States, 11023
        • Long Island GI Research Group
    • North Carolina
      • Harrisburg, North Carolina, United States, 28075
        • Carolina Digestive Health Associates
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Regional Gastroenterology Associates of Lancaster
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Southeastern Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
multi-dose preparation for oral administration prior to colonoscopy
multi-dose preparation for oral administration prior to colonoscopy
Active Comparator: 2
multi-dose preparation for oral administration prior to colonoscopy
multi-dose preparation for oral administration prior to colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Preparation Quality Using a 4 Point Scale
Time Frame: 2-day
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
2-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Chemistry Results (mEq/L)
Time Frame: 2 days
Change from Baseline
2 days
Hematology Results (%)
Time Frame: 2 days
Change from Baseline
2 days
Serum Chemistry Results (U/L)
Time Frame: 2 days
Change from Baseline
2 days
Serum Chemistry Results (mg/dL)
Time Frame: 2 days
Change from Baseline
2 days
Serum Chemistry Results (g/dL)
Time Frame: 2 days
Change from Baseline
2 days
Hematology Results - Hemoglobin
Time Frame: 2 days
Change from Baseline
2 days
Hematology Results (1000/MCL)
Time Frame: 2 days
Change from Baseline
2 days
Hematology Results - Red Blood Cells
Time Frame: 2 days
Change from Baseline
2 days
Serum Chemistry Results (Osmolality)
Time Frame: 2 days
Change from Baseline
2 days
Serum Chemistry Results (GFR)
Time Frame: 2 days
Change from Baseline
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: John D McGowan, Braintree Laboratories

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 18, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

August 15, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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