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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00756977
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : August 9, 2013
Last Update Posted : August 15, 2013
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

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

Condition or disease Intervention/treatment Phase
Colon Cancer Drug: BLI850 Drug: polyethylene glycol 3350 based bowel preparation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 394 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Study Start Date : August 2008
Actual Primary Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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"


Secondary Outcome Measures :
  1. Serum Chemistry Results (mg/dL) [ 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 (mEq/L) [ Time Frame: 2 days ]
    Change from Baseline

  5. Serum Chemistry Results (g/dL) [ Time Frame: 2 days ]
    Change from Baseline

  6. Serum Chemistry Results (GFR) [ Time Frame: 2 days ]
    Change from Baseline

  7. Hematology Results (1000/MCL) [ Time Frame: 2 days ]
    Change from Baseline

  8. Hematology Results - Hemoglobin [ 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756977


Locations
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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
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Study Director: John D McGowan Braintree Laboratories
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Responsible Party: Braintree Laboratories
ClinicalTrials.gov Identifier: NCT00756977    
Other Study ID Numbers: BLI850-301
BLI850-301
First Posted: September 22, 2008    Key Record Dates
Results First Posted: August 9, 2013
Last Update Posted: August 15, 2013
Last Verified: August 2013
Keywords provided by Braintree Laboratories:
Colonoscopy
screening
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Polyethylene glycol 3350
Laxatives
Gastrointestinal Agents