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BLI850-302: BLI850 vs an Approved 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: NCT00756548
Recruitment Status : Completed
First Posted : September 22, 2008
Results First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Braintree Laboratories

Tracking Information
First Submitted Date  ICMJE September 18, 2008
First Posted Date  ICMJE September 22, 2008
Results First Submitted Date  ICMJE February 19, 2013
Results First Posted Date  ICMJE December 27, 2013
Last Update Posted Date December 27, 2013
Study Start Date  ICMJE August 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
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")
Original Primary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
Efficacy - Preparation Quality Using a 4 Point Scale [ Time Frame: 2 - day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2008)
Safety - preparation related side effects, chemistry/hematology [ Time Frame: 2 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Official Title  ICMJE BLI850-302: BLI850 vs an Approved Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Colon Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2013)
386
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2008)
360
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00756548
Other Study ID Numbers  ICMJE BLI850-302
BLI850-302
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Braintree Laboratories
Study Sponsor  ICMJE Braintree Laboratories
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Braintree Laboratories
Verification Date December 2013

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