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

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BLI850
polyethylene glycol 3350 based bowel preparation
Sponsored by
Braintree Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Colonoscopy, screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of South Alabama
  • Jupiter Research
  • Miami Research Associates
  • United Medical Research
  • Atlanta Gastroenterology Associates
  • Delta Research Partners
  • Maryland Digestive Disease Research
  • Long Island GI Research Group
  • Carolina Digestive Health Associates
  • Wake Research Associates
  • Regional Gastroenterology Associates of Lancaster
  • Southeastern Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

multi-dose preparation for oral administration prior to colonoscopy

multi-dose preparation for oral administration prior to colonoscopy

Outcomes

Primary Outcome Measures

Efficacy - Preparation Quality Using a 4 Point Scale
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"

Secondary Outcome Measures

Serum Chemistry Results (mg/dL)
Change from Baseline
Hematology Results (%)
Change from Baseline
Serum Chemistry Results (U/L)
Change from Baseline
Serum Chemistry Results (mEq/L)
Change from Baseline
Serum Chemistry Results (g/dL)
Change from Baseline
Serum Chemistry Results (GFR)
Change from Baseline
Hematology Results (1000/MCL)
Change from Baseline
Hematology Results - Hemoglobin
Change from Baseline
Hematology Results - Red Blood Cells
Change from Baseline
Serum Chemistry Results (Osmolality)
Change from Baseline

Full Information

First Posted
September 18, 2008
Last Updated
August 9, 2013
Sponsor
Braintree Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00756977
Brief Title
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Official Title
BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Braintree Laboratories

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Colonoscopy, screening

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
394 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
multi-dose preparation for oral administration prior to colonoscopy
Arm Title
2
Arm Type
Active Comparator
Arm Description
multi-dose preparation for oral administration prior to colonoscopy
Intervention Type
Drug
Intervention Name(s)
BLI850
Intervention Description
multi-dose preparation for oral administration prior to colonoscopy
Intervention Type
Drug
Intervention Name(s)
polyethylene glycol 3350 based bowel preparation
Intervention Description
multi-dose preparation for oral administration prior to colonoscopy
Primary Outcome Measure Information:
Title
Efficacy - Preparation Quality Using a 4 Point Scale
Description
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
Time Frame
2-day
Secondary Outcome Measure Information:
Title
Serum Chemistry Results (mg/dL)
Description
Change from Baseline
Time Frame
2 days
Title
Hematology Results (%)
Description
Change from Baseline
Time Frame
2 days
Title
Serum Chemistry Results (U/L)
Description
Change from Baseline
Time Frame
2 days
Title
Serum Chemistry Results (mEq/L)
Description
Change from Baseline
Time Frame
2 days
Title
Serum Chemistry Results (g/dL)
Description
Change from Baseline
Time Frame
2 days
Title
Serum Chemistry Results (GFR)
Description
Change from Baseline
Time Frame
2 days
Title
Hematology Results (1000/MCL)
Description
Change from Baseline
Time Frame
2 days
Title
Hematology Results - Hemoglobin
Description
Change from Baseline
Time Frame
2 days
Title
Hematology Results - Red Blood Cells
Description
Change from Baseline
Time Frame
2 days
Title
Serum Chemistry Results (Osmolality)
Description
Change from Baseline
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 At least 18 years of age. Otherwise in good health, as determined by physical exam and medical history. 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). Negative urine pregnancy test at screening, if applicable. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study. Exclusion Criteria: Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or megacolon. Subjects with impaired consciousness that predisposes them to pulmonary aspiration. Subjects who are undergoing colonoscopy for foreign body removal or decompression. Subjects with clinically significant electrolyte abnormalities based on Visit 1 laboratory results. Subjects who had previous significant gastrointestinal surgeries (e.g. colostomy, colectomy, gastric bypass). Subjects who are pregnant or lactating, or intending to become pregnant during the study. Subjects of childbearing potential who refuse a pregnancy test. Subjects who are allergic to any preparation components Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John D McGowan
Organizational Affiliation
Braintree Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Jupiter Research
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
United Medical Research
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Atlanta Gastroenterology Associates
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Maryland Digestive Disease Research
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Long Island GI Research Group
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Carolina Digestive Health Associates
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Regional Gastroenterology Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Southeastern Clinical Research
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States

12. IPD Sharing Statement

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

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