BLI850 vs an Active Control Bowel Preparation in Adult Subjects Undergoing Colonoscopy
1 other identifier
interventional
394
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 18, 2008
CompletedFirst Posted
Study publicly available on registry
September 22, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedResults Posted
Study results publicly available
August 9, 2013
CompletedAugust 15, 2013
August 1, 2013
3 months
September 18, 2008
February 19, 2013
August 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy - Preparation Quality Using a 4 Point Scale
Percentage of patients with a successful preparation (cleaning rated as "Good" or "Excellent"
2-day
Secondary Outcomes (10)
Serum Chemistry Results (mg/dL)
2 days
Hematology Results (%)
2 days
Serum Chemistry Results (U/L)
2 days
Serum Chemistry Results (mEq/L)
2 days
Serum Chemistry Results (g/dL)
2 days
- +5 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALmulti-dose preparation for oral administration prior to colonoscopy
2
ACTIVE COMPARATORmulti-dose preparation for oral administration prior to colonoscopy
Interventions
multi-dose preparation for oral administration prior to colonoscopy
Eligibility Criteria
You may qualify if:
- 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.
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University of South Alabama
Mobile, Alabama, 36693, United States
Jupiter Research
Jupiter, Florida, 33458, United States
Miami Research Associates
Miami, Florida, 33143, United States
United Medical Research
New Smyrna Beach, Florida, 32168, United States
Atlanta Gastroenterology Associates
Roswell, Georgia, 30076, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Maryland Digestive Disease Research
Laurel, Maryland, 20707, United States
Long Island GI Research Group
Great Neck, New York, 11023, United States
Carolina Digestive Health Associates
Harrisburg, North Carolina, 28075, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
Southeastern Clinical Research
Chattanooga, Tennessee, 37403, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- John McGowan
- Organization
- Braintree Laboratories
Study Officials
- STUDY DIRECTOR
John D McGowan
Braintree Laboratories
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2008
First Posted
September 22, 2008
Study Start
August 1, 2008
Primary Completion
November 1, 2008
Last Updated
August 15, 2013
Results First Posted
August 9, 2013
Record last verified: 2013-08