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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756548
First Posted: September 22, 2008
Last Update Posted: December 27, 2013
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.
Information provided by (Responsible Party):
Braintree Laboratories
September 18, 2008
September 22, 2008
February 19, 2013
December 27, 2013
December 27, 2013
August 2008
November 2008   (Final data collection date for primary outcome measure)
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")
Efficacy - Preparation Quality Using a 4 Point Scale [ Time Frame: 2 - day ]
Complete list of historical versions of study NCT00756548 on ClinicalTrials.gov Archive Site
  • Serum Chemistry Results (mEq/L) [ Time Frame: 2 days ]
    Change from Baseline
  • Hematology Results (%) [ Time Frame: 2 days ]
    Change from Baseline
  • Serum Chemistry Results (U/L) [ Time Frame: 2 days ]
    Change from Baseline
  • Serum Chemistry Results (mg/dL) [ Time Frame: 2 days ]
    Change from Baseline
  • Serum Chemistry Results (g/dL) [ Time Frame: 2 days ]
    Change from Baseline
  • Serum Chemistry Results - Glomerular Filtration Rate [ Time Frame: 2 days ]
    Change from Baseline
  • Hematology Results - Hemoglobin [ Time Frame: 2 days ]
    Change from Baseline
  • Hematology Results (1000/MCL) [ Time Frame: 2 days ]
    Change from Baseline
  • Hematology Results - Red Blood Cells [ Time Frame: 2 days ]
    Change from Baseline
  • Serum Chemistry Results (Osmolality) [ Time Frame: 2 days ]
    Change from Baseline
Safety - preparation related side effects, chemistry/hematology [ Time Frame: 2 days ]
Not Provided
Not Provided
 
BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Colon Cancer
  • Drug: BLI850
    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
  • Experimental: 1
    multi-dose preparation for oral administration prior to colonoscopy
    Intervention: Drug: BLI850
  • Active Comparator: 2
    multi-dose preparation for oral administration prior to colonoscopy
    Intervention: Drug: polyethylene glycol 3350 based bowel preparation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
386
Not Provided
November 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00756548
BLI850-302
BLI850-302
No
Not Provided
Not Provided
Braintree Laboratories
Braintree Laboratories
Not Provided
Not Provided
Braintree Laboratories
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP